Technical Guide Technical Information and Efficacy Data
TABLE OF CONTENTS Hand Hygiene PURELL Instant Hand Sanitizer 1 PURELL Instant Hand Sanitizer with Aloe 2 PURELL Instant Hand Sanitizer Lasting Care Formula 4 PURELL Instant Hand Sanitizer with DERMAGLYCERIN SYSTEM 5 PURELL Foaming Hand Sanitizer 7 PURELL Instant Hand Sanitizer Food Code Compliant 8 PROVON Antimicrobial Skin Cleanser with 2% CHG 9 PROVON Medicated Lotion Soap with Chloroxylenol 13 PROVON Medicated Lotion Soap with Triclosan 14 PROVON Antimicrobial Lotion Soap with 0.3% Chloroxylenol 15 PROVON Gentle Lotion Soap 16 PROVON Mild Lotion Soap 16 PROVON Enriched Lotion Cleanser 17 PROVON Foaming Handwash with Moisturizers 17 PROVON Foaming Antimicrobial Handwash with Moisturizers and 0.3% Chloroxylenol 18 PROVON Foaming Medicated Handwash with Moisturizers and 0.5% Triclosan 19 Bathing & Moisturizing PROVON Antibacterial Body Wash 22 PROVON Moisturizing Bathing Cloths 23 PROVON Conditioning Shampoo & Body Wash 24 PROVON Tearless Shampoo & Body Wash 24 PROVON Enriched Shampoo for Body & Hair 25 PROVON Foaming Hair & Body Wash with Moisturizers 25 PROVON Moisturizing Hand & Body Lotion 26 PROVON Skin Moisturizer with Aloe & Vitamins 27 Perineal Skin Care PROVON Perineal Wash 27 PROVON Antibacterial Perineal Wash 28 PROVON Personal Wash Cloths 29 PROVON Moisturizing Perineal Skin Protectant with Petrolatum 29 PROVON Perineal Cream 30 PROVON Perineal Ointment with Petrolatum 30 Glossary of Terms Glossary of Terms Inside Back Cover
Hand Hygiene PURELL Instant Hand Sanitizer Dermatologist-tested, dye-free. Latex compatible. CHG compatible. Stock No. 9651, 9652, 9654, 9656, 9657, 9659, 9661, 7187, 2256, 2156, 9605, 9606, 3020, 9584, 3005, 9650 Color: Clear : Citrus Viscosity: 6,000-25,000 cps (gel) ph: 4.5-9.5 Objective: Evaluation of irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay. Method: The method is that summarized by Phillips et al. (Toxic and Applied Pharmacology 21:369-382, 1972). The fresh materials are applied five (5) days weekly for twenty-one (21) days to the same site. Patches are not reapplied on weekends (or holidays); they remain in place for these periods. There are fifteen (15) days of reading, even when holidays intervene. Date: February 27, 1998 Results: Average score 0.05 (scale 0-4). Lower scores indicate lower potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Human Repeated Insult Patch Test Objective: Determination of the dermal irritation and sensitization potential of the product. Description of Test: Human repeated patch test. Method: This study was conducted utilizing a standard protocol and a total of two hundred and fifteen (215) subjects. Prior to patch application, the test area was wiped with seventy percent (70%) ethanol and allowed to dry. The test material was applied under a semi-occlusive patch (Readi-Bandage ) to the upper back (between the scapulae) and allowed to remain in direct skin contact for twenty-four (24) hours. Patches were applied to the same site on Monday, Wednesday and Friday for a three (3)-week induction period. The sites were graded for dermal irritation and sensitization twenty-four (24) hours after removal of the patches on Tuesday and Thursday, and forty-eight (48) hours after patch removal on Saturday. Standard Dermal Scores (0-4+) were used to record dermal reactions. After two (2) weeks, the subjects were rechallenged and evaluated forty-eight (48) and seventy-two (72) hours after patch removal. Independent Laboratory: Clinical Research Laboratories, Inc., Piscataway, New Jersey. Date: April 30, 2002 Results: No dermal reactions were observed during the induction or challenge phases of the study. Conclusion: Test product did not demonstrate potential for eliciting a dermal irritation or sensitization. Efficacy Data In Vitro Objective: These tests were designated to evaluate the antimicrobial effectiveness of product formulations when challenged with a broad spectrum of microorganisms. Description of Test: Fifteen (15) second exposure kill studies were performed utilizing thirtyfour (34) challenge microorganisms. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge micro-organisms. Independent Laboratories: BioScience Laboratories, Bozeman, Montana; November 3, 1999; March 9, 1998. February 9, 2001. Percent Reduction of Test Organisms After a 15-Second Exposure Microorganism ATCC No. % Reduction Acinetobacter baumannii 19606 >99.999 Bacillus megaterium 14581 >99.998 Citrobacter freundii 8090 >99.999 Clostridium difficile 9689 99.998 Corynebacterium diphtheriae 11913 >99.999 Enterobacter aerogenes 13048 >99.999 Enterococcus faecalis Vancomycin resistant 51575 >99.999 Enterococcus faecium Vancomycin resistant 51559 >99.999 Escherichia coli 11229 >99.999 Escherichia coli (O157; H7) 35150 >99.999 Klebsiella ozaenae 11296 >99.999 Klebsiella pneumoniae 13883 >99.999 Lactobacillus plantarum 14917 >99.999 Listeria monocytogenes 15313 >99.999 Proteus mirabilis 7002 >99.999 Proteus vulgaris 13315 >99.999 Pseudomonas aeruginosa 15442 >99.999 Salmonella enteritidis 13076 >99.999 Salmonella typhimurium 14028 >99.999 Serratia marcescens 14756 >99.999 Shigella dysenteriae 13313 >99.999 Shigella sonnei 11060 >99.999 Staphylococcus aureus Methicillin resistant 33591 >99.999 Staphylococcus aureus Vancomycin intermediate Methicillin resistant Clinical Isolate >99.999 Staphylococcus epidermidis 12228 >99.999 Streptococcus pneumoniae 33400 99.994 Streptococcus pyogenes 19615 >99.999 Yeasts and Fungi Aspergillus flavus 9643 >99.999 Aspergillus niger 9642 >99.998 Candida albicans 14053 >99.999 Candida tropicalis 13803 >99.999 Epidermophyton floccosum 52063 >99.988 Penicillium citrinum 9849 >99.999 Trichophyton metagropytes 9533 >99.999 Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria, yeasts, and fungi was demonstrated. 1
PURELL Instant Hand Sanitizer (continued) Efficacy Data In Vitro Virus Test Description of Test: A suspension of challenge virus was exposed to product. An aliquot was removed and neutralized at the 30- second exposure by serial dilution and then assayed for the presence of viable virus. The following controls were assayed in parallel: positive virus, cytotoxicity, and neutralization. Independent Test Laboratory: ViroMed Laboratories, Inc., Minneapolis, Minnesota; April 29, 1998; September 23, 1998, November 4, 1998. Percent Reduction of Test Organisms After a 30-Second Exposure Microorganism ATCC No. % Reduction Adenovirus type 2 VR-846 95.195 Coxsackievirus B3 VR-30 99.822 Hepatitis A Virus VR-1073** 94.377 Herpes Simplex Virus Type 1 VR-733 99.999 HIV type 1 HTLV-IIIB 99.993 Influenza Virus Type A 2 VR-544 99.999 Parainfluenza Virus Type 2 VR-92 99.996 Parainfluenza Virus Type 3 VR-93 99.993 Rhinovirus Type 14 VR-284 99.438 Rhinovirus Type 16 VR-1126 99.994 Rhinovirus Type 37 VR-1147 99.822 ** Variant 18F PURELL Instant Hand Sanitizer with Aloe Latex compatible. CHG compatible. Stock No. 9637, 9631, 9639, 2237, 2137, 9682, 9641 Color: Clear, Green : Pleasant Floral Viscosity: 6,000-25,000 cps (gel) ph: 4.5-9.5 Objective: Evaluation of irritation potential in humans. Description of Test: 21-Day Cumulative Irritancy. Method: The method is that summarized by Phillips et al. (Toxic and Applied Pharmacology 21:369-382, 1972). The fresh materials are applied five (5) days weekly for twenty-one (21) days to the same site. Patches are not reapplied on weekends (or holidays); they remain in place for these periods. There are fifteen (15) days of reading, even when holidays intervene. Date: July 5, 2002 Results: Average scores 0.06 (Scale 0-4) Conclusion: Product has a very low potential for eliciting skin irritation and allergic contact dermatitis. Human Repeated Insult Patch Test Active Ingredient Ethyl Alcohol 62% Also Contains: Water Carbomer Tocopheryl Acetate (Vitamin E) Glycerin Propylene Glycol Isopropyl Myristate Aminomethyl Propanol Antimicrobial Diluent Thickener,, Emollient Objective: Evaluation of skin irritation and sensitization potential in humans. Description of Test: Human repeated insult patch test. Method: This study was conducted utilizing a standard protocol and a total of one hundred and four (104) subjects. Prior to patch application, the test area was wiped with seventy percent (70%) ethanol and allowed to dry. The test material was applied under a semi-occlusive patch (Readi-Bandage ) to the upper back (between the scapulae) and allowed to remain in direct skin contact for twenty-four (24) hours. Patches were applied to the same site on Monday, Wednesday and Friday for a three (3)-week induction period. The sites were graded for dermal irritation and sensitization twenty-four (24) hours after removal of the patches on Tuesday and Thursday, and forty-eight (48) hours after patch removal on Saturday. Standard Dermal Scores (0-4+) were use to record dermal reactions. After two (2) weeks, the subjects were rechallenged and evaluated forty-eight (48) and seventy-two (72) hours after patch removal. Independent Laboratory: Clinical Research Laboratories, Inc., Piscataway, New Jersey. Date: September 10, 1997 Results: No observed dermal reactions. Conclusion: No demonstrated potential for eliciting dermal irritation or sensitization. 2
PURELL Instant Hand Sanitizer with Aloe (continued) Efficacy Data In Vitro Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15) second exposure kill studies were performed utilizing twelve (12) challenge bacteria. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Lab: BioScience Laboratories, Inc., Bozeman, Montana Independent Test Labortory, Minneapolis, Minn. Date: September 8, 1997 Percent Reduction of Test Organisms after a 15-Second Exposure Microorganism ATCC No. % Reduction Clostridium difficile 9689 99.99 Enterococcus faecalis Vancomycin resistant 51575 >99.99 Enterococcus faecium Vancomycin resistant 51559 >99.99 Escherichia coli 11229 >99.99 Listeria monocytogenes 7644 >99.99 Pseudomonas aeruginosa 15442 >99.99 Salmonella typhimurium 14028 >99.99 Serratia marcescens 14756 >99.99 Shigella dysenteriae 13313 >99.99 Shigella sonnei 11060 >99.99 Staphylococcus aureus 6538 >99.99 Streptococcus pyogenes 19615 >99.99 Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria was demonstrated. Active Ingredient Ethyl Alcohol 62% Also Contains: Water Glycerin Carbomer Aloe Barbadensis Leaf Juice Aminomethyl Propanol Propylene Glycol Isopropyl Myristate Tocopheryl Acetate Yellow No. 5 Blue No. 1 Antimicrobial Diluent, Thickener Botanical Additive, Skin Conditioning, Emollient 3
PURELL Instant Hand Sanitizer Lasting Care Formula Latex compatible. Stock No. 9671, 9672, 2176 Color: Clear : Citrus Viscosity: 6,000-25,000 cps ph: 4.5-9.5 Objective: Evaluation of skin irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Method: The method is that summarized by Phillips et al. (Toxic and Applied Pharmacology 21:369-382, 1972). The fresh materials are applied five (5) days weekly for twenty-one (21) days to the same site. Patches are not reapplied on weekends (or holidays); they remain in place for these periods. There are fifteen (15) days of reading, even when holidays intervene. Date: November 12, 1998 Results: No dermal reactions were observed during the induction or challenge phases of the study. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Human Repeated Insult Patch Test Objective: Determination of the dermal irritation and sensitization potential of the product. Description of Test: Human repeated insult patch test. Method: This study was conducted utilizing a total of two hundred twenty one (221) subjects. The test material was applied under a semi-occlusive patch to the upper back and allowed to remain in direct skin contact for twenty-four (24) hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a three (3)-week induction period. The `sites were graded for dermal irritation and sensitiza tion twenty-four (24) hours after removal of the patches on Tuesday and Thursday, and forty-eight (48) hours after patch removal on Saturday. Standard Dermal Scores (0-4+) were used to record dermal reactions. Human Repeated Insult Patch Test (continued) Independent Laboratory: Clinical Research Laboratories, Inc. Piscataway, New Jersey. Date: October, 1999. Results: No dermal reactions were observed during the induction or challenge phases of the study. Conclusion: Test product demonstrated no clinically significant potential for eliciting either dermal irritation or sensitization. Efficacy Data-- In Vitro Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15)-second exposure kill studies were performed using twenty-five (25) challenge microorganisms. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: September, 1999. Percent Reduction of Test Organisms After a 15-Second Exposure Microorganism ATCC No. % Reduction Acinetobacter baumannii 19606 >99.999 Bacillus megaterium 14581 >99.996 Citrobacter freundii 8090 >99.999 Clostridium difficile 9689 >99.999 Corynebacterium diphtheriae 11913 >99.999 Enterobacter aerogenes 13048 >99.999 Enterococcus faecalis Vancomycin resistant 51575 >99.999 Enterococcus faecium Vancomycin resistant 51559 >99.999 Escherichia coli 11229 >99.999 Escherichia coli (O157; H7) 35150 >99.999 Klebsiella ozaenae 11296 >99.999 Klebsiella pneumoniae 13883 >99.999 Lactobacillus plantarum 14917 >99.996 Listeria monocytogenes 15313 >99.999 Proteus mirabilis 7002 >99.999 Proteus vulgaris 13315 >99.999 Pseudomonas aeruginosa 15442 >99.999 Salmonella enteritidis 13076 >99.999 Salmonella typhimurium 14028 >99.999 Serratia marcescens 14756 >99.999 Shigella dysenteriae 13313 >99.999 Shigella sonnei 11060 >99.999 Staphylococcus aureus Methicillin resistant 33591 >99.999 Staphylococcus epidermidis 12228 >99.999 Streptococcus pyogenes 19615 >99.999 Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria was demonstrated. 4
PURELL Instant Hand Sanitizer Lasting Care Formula (continued) Persistence Data Objective: Evaluate the persistent antibacterial efficacy of the product on the skin. Description of Test: Persistent antimicrobial efficacy of the product was performed by measuring the inhibition of a marker microorganism (Staphylococcus aureus ATCC #6538) on an agar plate following exposure to forearm skin. Twelve subjects were randomly assigned to the control group in which no product was applied to the forearm skin. Ten subjects each were randomly assigned to one of the two post-application intervals (4-hour and 6-hour). The marker organism plates were applied to the volar forearms of the subjects for a total of 30 minutes. The agar plates were incubated at 30 C for 24-48 hours. Independent Laboratory: BioScience Laboratory Inc., Bozeman, MT Date: September 27, 1999. Conclusion: The product resulted in significant inhibition of the marker microorganism after 4-hour and 6-hour post product application. PURELL Instant Hand Sanitizer with DERMAGLYCERIN SYSTEM Latex compatible. Vinyl compatible. Nitrile compatible. CHG compatible. Stock No. 9648, 9691, 9646, 2151 Active Ingredient: 62% Ethyl Alcohol Color: White opaque solution : Mild alcohol odor with herbal fragrance Form: Liquid ph: 4.5-9.5 Objective: Evaluation of skin irritation potential in humans. Method: Phillips et al (Toxic and Applied Pharmacology 21: 369-382) summarizes the method utilized for this evaluation. Fresh materials are applied daily, 5 days per week, for 21 days to the same site (patches were not moved or reapplied on the weekends). Laboratory, San Francisco, CA Date: 26 July 2004 Results: Average Score = 0.06 (scale 0-4); No sensitization occurred. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Active Ingredient Ethyl Alcohol 62% Also Contains: Glycerin Isopropyl Myristate Propylene Glycol Retinyl Palmitate Tocopheryl Acetate Zea Mays (Corn Oil) Acrylates/C10-30 Alkyl Acrylate Crosspolymer Aminomethyl Propanol (Parfum) Triclosan Antimicrobial Diluent Skin Conditioning, Emollient, Skin Conditioning Skin Conditioning Skin Conditioning Thickener Efficacy Data In Vivo Objective: This study evaluated the antimicrobial effectiveness of one (1) test products and one (1) reference product using a Healthcare Personnel Handwash Procedure, as per methodology specified by the Food and Drug Administration (FR 59:116, 17 June 94, pp. 31448-31450). Description of Test: The antimicrobial effectiveness of one (1) test product and one (1) reference product for use as Health Care Personnel Handwashes was determined using ten (10) consecutive hand contamination/product application procedures. Serratia marcescens (ATCC #14756) was the marker organism used for hand contaminations. Eighteen (18) human subjects were utilized for the test and referenced product, for a total of thirty-six (36) subjects. Microbial samples were taken at baseline and after washes one (1), three (3), seven (7), and ten (10). All sampling of the hands was performed using the Glove Juice Sampling Procedure. The testing methods were based on the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of an Antiseptic Handwash or Health Care Personnel Handwash (FR 59:116, 17 June 94, pp. 31448-31450). Independent Laboratory: BioScience Laboratories, Inc., Bozeman, MT Date: June 24, 2004 Results: Wash Number Reduction from Baseline Log 10 1 3.33 3 3.75 7 3.59 10 3.17 5
PURELL Instant Hand Sanitizer with DERMAGLYCERIN SYSTEM (continued) Conclusions: Test product produced statistically significant (p < 0.05) Log10 reductions in bacterial populations from baseline populations of 3.33 after Wash 1 and 3.17 after Wash 10. The critical indices of this study were a two (2) Log10 reduction after Wash 1 and a three (3) Log10 reduction after Wash 10. The test product met these criteria. Efficacy Data-- In Vitro Objective: Evaluate the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15) second exposure kill evaluations were performed utilizing forty two (42) challenge bacterial strains. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: June 23, 2004. Percent Reduction of Test Organisms after a 15-Second Exposure Challenge Microbe ATCC No. % Reduction Acinetobacter baumannii 19606 >99.9999 Bacillus megaterium 14581 >99.9985 Bacteroides fragilis 29762 >99.9999 Campylobacter jejuni 29428 >99.9999 Citrobacter freundii 8090 >99.9998 Clostridium difficile 9689 >99.9999 (vegetative cells) Clostridium perfringens 13124 >99.9912 (vegetative cells) Corynebacterium diphtheriae 11913 >99.9999 Enterobacter aerogenes 13048 >99.9999 Enterococcus faecalis (VRE) 51575 >99.9999 Enterococcus faecalis 29212 >99.9999 Enterococcus faecium (VRE) 51559 >99.9999 Escherichia coli 11229 >99.9999 Escherichia coli 25922 >99.9998 Escherichia coli (O157:H7) 35150 >99.9998 Haemophilus influenzae 33930 >99.9999 Klebsiella pneumoniae 11296 >99.9999 Subsp.ozaenae Klebsiella pneumoniae 13883 >99.9999 Subsp.pneumoniae Lactobacillus plantarum 14917 >99.9999 Listeria monocytogenes 7644 >99.9999 Listeria monocytogenes 15313 >99.9999 Micrococcus luteus 7468 >99.9997 Proteus mirabilis 7002 >99.9999 Proteus vulgaris 13315 >99.9999 Pseudomonas aeruginosa 15442 >99.9999 Pseudomonas aeruginosa 27853 >99.9999 Salmonella choleraesuis 10708 >99.9999 Serotype Choleraesuis Salmonella choleraesuis 13076 >99.9999 Serotype Enteritidis Salmonella choleraesuis 14028 >99.9999 Serotype Typhimurium Serratia marcescens 14756 >99.9999 Shigella dysenteriae 13313 >99.9999 Shigella sonnei 11060 >99.9999 Staphylococcus aureus 6538 >99.9999 Active: Challenge Microbe ATCC No. % Reduction Staphylococcus aureus 29213 >99.9999 Staphylococcus aureus 33591 >99.9999 (MRSA) Staphylococcus aureus 042800VISA* >99.9999 (VIMRSA) Staphylococcus epidermidis 12228 >99.9999 Staphylococcus haemolyticus 43253 >99.9999 Staphylococcus hominis 29885 >99.9999 Staphylococcus 49453 >99.9999 saprophyticus Streptococcus pneumoniae 33400 >99.9993 Streptococcus pyogenes 19615 >99.9999 Yeasts and Fungi ATCC No. % Reduction Aspergillus flavus 9643 >99.9999 Aspergillus niger 9642 >99.3984 Candida albicans 14053 >99.9999 Candida tropicalis 13803 >99.9999 Epidermophyton floccosum 52063 >99.9895 Penicillium citrinum 9849 >99.9995 Trichophyton mentagrophytes 9533 >99.9997 VISA - Vanncomycin-Intermediate Staphylococcus aureus MRSA - Methicillin-Resistant Staphylococcus aureus *=BSLI Clinical Isolate number Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria, yeasts and fungi was demonstrated. INCI Name* Ethyl Alcohol 62% Antimicrobial Also Contains: Cyclomethicone Cetearyl Isononanoate Propylene Glycol Carbomer Viscosity Increasing Styrene/Acrylates Copolymer Viscosity Increasing Glycerin Cetyl Lactate Diazolidinyl Urea Aminomethyl Propanol ph adjuster C12-15 Alkyl Benzoate Methylparaben (Parfum) PEG-4 Solvent Propylparaben Iodopropynyl Butylcarbamate Tocopheryl Acetate Cacamidopropyl PG- Conditioning Dimonium Chloride Phosphate *International Nomenclature Cosmetic Ingredient 6
PURELL Foaming Hand Sanitizer Product meets the Protocol for Healthcare Personnel Handwash. Latex compatible. CHG compatible. Stock No. 9698 Active Ingredient: 62% Ethyl Alcohol Color: White foam : Mild alcohol odor Form: Foam ph: 7.0-8.0 Objective: Evaluation of skin irritation potential in humans. Description of Test: 21 Day Cumulative Irritancy Assay with Challenge. Fresh materials are applied daily, 6 days per week, for 21 days to the same site (patches were not moved or reapplied on Sunday). Independent Laboratory: RCTS, Inc., Irving, TX Date: January 3, 2003 Results: Average Score = 0.02 (scale 0 4); No sensitization occurred. Conclusion: The product has a low potential for skin irritation and allergic contact dermatitis. Human Repeated Insult Patch Test Objective: Determination of the dermal irritation and sensitization potential of the product. Description of Test: Human repeated insult patch test. Independent Laboratory: Clinical Research Laboratories, Inc., Piscataway, New Jersey. Date: February 25, 2003 Results: No visible skin reactions were observed during the induction or challenge phases of the study. Conclusion: Test product demonstrated no potential for eliciting either dermal irritation or sensitization. Efficacy Data In Vivo Healthcare Personnel Handwash Data Objective: This study evaluated the antimicrobial effectiveness of one (1) test product and one (1) reference product using a Healthcare Personnel Handwash Procedure, as per methodology specified by the Food and Drug Administration (FR 59:116, 17 June 94, pp. 31448-31450). Description of Test: The antimicrobial effectiveness of one (1) test product and one (1) reference product for use as Health Care Personnel Handwashes was determined using ten (10) consecutive hand contamination/product application procedures. Serratia marcescens (ATCC #14756) was the marker organism used for hand contaminations. Eighteen (18) human subjects were utilized for the test and referenced product, for a total of thirty-six (36) subjects. Microbial samples were taken at baseline and after washes one (1), three (3), seven (7), and ten (10). All sampling of the hands was performed using the Glove Juice Sampling Procedure. The testing methods were based on the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of an Antiseptic Handwash or Health Care Personnel Handwash (FR 59:116, 17 June 94, pp. 31448-31450). Independent Laboratory: BioScience Laboratories, Inc., Bozeman, MT Date: January 22, 2003 Results: Wash Number Reduction from Baseline Log 10 1 3.29 3 2.82 7 2.95 10 3.12 Conclusions: Test product produced statistically significant (p < 0.05) Log 10 reductions in bacterial populations from baseline populations of 3.29 after Wash 1 and 3.12 after Wash 10. The critical indices of this study were a two (2) Log 10 reduction after Wash 1 and a three (3) Log 10 reduction after Wash 10. The test product met these criteria. Active: INCI Name* Ethyl Alcohol 62% Antimicrobial Also Contains: Hydrofluorocarbon 152a Isobutane Emulsifying Wax NF Cetyl Lactate Steareth-2 Propane Sodium Benzoate Sodium Sesquicarbonate (Parfum) Propellant Propellant Stabilizer Emollient Emulsifying Propellant Ingredient ph adjuster *International Nomenclature Cosmetic Ingredient 7
PURELL Foaming Hand Sanitizer (continued) Efficacy Data In Vitro Timed-Exposure Kill Tests Objective: Evaluate the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15) or thirty (30) second exposure kill evaluations were performed utilizing twenty-seven (27) challenge bacterial strains. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 or 30 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: January 28, 2003. Results: Percent Reduction of Test Organisms After a 15-Second Exposure Challenge Microbe ATCC No. % Reduction Acinetobacter 19606 >99.9999 baumannii Campylobacter jejuni 29428 >99.9995 Citrobacter freundii 8090 >99.9999 Clostridium difficile 9689 >99.9999 Corynebacterium 11913 >99.9998 diphtheriae Enterobacter aerogenes 13048 >99.9993 Enterococcus faecalis 51575 >99.9999 (VRE) Enterococcus faecium 51559 >99.9999 (VRE) Escherichia coli 11229 >99.9999 Escherichia coli (O157:H7) 35150 >99.9998 Klebsiella pneumoniae 11296 >99.9999 Subsp.ozaenae Klebsiella pneumoniae 13883 >99.9999 Subsp.pneumoniae Lactobacillus plantarum 14917 >99.9998 Listeria monocytogenes 15313 >99.9999 Proteus mirabilis 7002 >99.9999 Proteus vulgaris 13315 >99.9983 Pseudomonas aeruginosa 15442 >99.9999 Salmonella choleraesuis 13076 >99.9999 Serotype Enteritidis Salmonella choleraesuis 14028 >99.9999 Serotype Typhimurium Serratia marcescens 14756 >99.9999 Shigella dysenteriae 13313 >99.9999 Shigella sonnei 11060 >99.9999 Staphylococcus aureus 33591 >99.9999 (MRSA) Staphylococcus aureus 03230 >99.9999 (MRSA) 1MMRSa4* Staphylococcus 12228 >99.9999 epidermidis Streptococcus pneumoniae 33400 >99.9999 Streptococcus pyogenes 19615 >99.9999 PURELL Instant Hand Sanitizer Food Code Compliant Latex compatible. Stock No. 2166, 9666, 2006, 9660 Active Ingredient: 62% Ethyl Alcohol Color: Clear to hazy solution : Mild alcohol odor with lemon fragrance Form: Liquid ph: 4.5-9.5 Objective: Evaluation of skin irritation potential in humans. Method: Phillips et al (Toxic and Applied Pharmacology 21: 369-382) summarizes the method utilized for this evaluation. Fresh materials are applied daily, 5 days per week, for 21 days to the same site (patches were not moved or reap plied on the weekends). Independent Laboratory: RCTS, Inc. Irving, Texas Date: January 3, 2003 Results: Average Score = 0.05 (scale 0-4); No sensitization occurred. Conclusion: The product has a low potential for skin irritation and allergic contact dermatitis. Efficacy Data-- In Vitro Objective: Evaluate the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15)-second exposure kill evaluations were performed utilizing twelve (12) challenge bacterial strains. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (30 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: January 9, 2003. *Clinical Isolate MRSA - Methicillin-Resistant Staphylococcus aureus 8
PURELL Instant Hand Sanitizer Food Code Compliant (continued) Percent Reduction of Test Organisms After a 30-Second Exposure Microorganism ATCC No. % Reduction Acinetobacter baumannii 19606 >99.999 Candida albicans 10231 >99.999 Enterobacter cloacae 13047 >99.999 Enterococcus faecium 51559 >99.999 Escherichia coli 25922 >99.999 Klebsiella pneumoniae 11296 >99.999 Micrococcus luteus 7468 >99.999 Proteus mirabilis 7002 >99.999 Pseudomonas aeruginosa 27853 >99.999 Serratia marcescens 14756 >99.999 Staphylococcus aureus 29213 >99.999 Staphylococcus 12228 >99.999 epidermidis PROVON Antimicrobial Skin Cleanser with 2% CHG Meets protocol for Healthcare Personnel Handwash, Surgical Scrub, Pre-Operative Skin Prep, Pre- Injection Skin Prep & Wound Cleanser. Latex Compatible. Stock No. 4106, 4104 Color: Clear Colorless to Clear Pink : Floral Viscosity: 1,000-4,000 cps ph: 4.50-6.80 Active Ingredient Ethyl Alcohol 62% Also Contains: Carbomer Glycerin (Parfum) Sodium Hydroxide Propylene Glycol Trocopheryl Acetate Antimicrobial Viscosity Increasing Objective: Evaluation of skin irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: October 17, 1997 Results: Average score 0.06 (scale 0-4). Lower scores indicate low potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Efficacy Data In Vitro Timed-Exposure Kill Tests Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen(15)-second-exposure kill studies were performed utilizing eighteen (18) challenge bacterial strains. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge micro-organisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: September 23, 1997 9
PROVON Antimicrobial Skin Cleanser with 2% CHG (continued) Efficacy Data In Vitro (continued) Percent Reduction of Test Organisms After a 15-Second Exposure Microorganism ATCC No. % Reduction Clostridium difficile 9689 >99.999 Enterococcus faecalis 19433 >99.999 Enterococcus faecalis Vancomycin resistant 51575 >99.999 Enterococcus faecium 19434 >99.999 Enterococcus faecium Vancomycin resistant 51559 >99.999 Escherichia coli 11229 >99.999 Escherichia coli (O157; H7) 35150 >99.999 Klebsiella ozaenae 11296 >99.999 Listeria monocytogenes 7644 >99.999 Proteus mirabilis 7002 >99.999 Pseudomonas aeruginosa 15442 >99.999 Salmonella typhimurium 14028 >99.999 Serratia marcescens 14756 >99.999 Shigella sonnei 11060 >99.999 Staphylococcus aureus 6538 >99.999 Staphylococcus aureus Methicillin resistant 33591 >99.999 Staphylococcus epidermidis 14990 >99.999 Streptococcus pyogenes 19615 >99.999 Conclusion: Very effective reduction of Gram- negative and Gram-positive bacteria by the product was demonstrated. Efficacy Data In Vivo Healthcare Personnel Handwash Data Objective: Evaluation of the antimicrobial effectiveness of the product on hands. Description of Test: This study evaluated both the immediate and persistent antimicrobial effects of the product over the course of ten (10) consecutive microbial contamination/product application cycles. The study utilized six (6) subjects for the product and six (6) subjects for the control. The protocol used was a modification of the ASTM Standard Method and the methods described in the Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, Federal Register, 59, No. 116, 31448-31450, 1994. This procedure involves determination of the reduction in transient bacteria on the hands determined by the Glove Juice Technique after Serratia marcescens contamination. Independent Laboratory: North American Science Associates, Inc., Northwood, Ohio. Date: February 28, 1986 Results: Reductions in recoverable Serratia marcescens counts. Summary: Both products demonstrated a good rate of kill and good residual activity throughout the course of this study. Efficacy Data MICs Minimum Inhibitory Concentrations (MICs) Objective: Demonstration of the broad spectrum of antimicrobial activity. Description of Test: Bacterial tests run with agar to determine the concentration of chlorhexidine gluconate required to inhibit growth. Reference: Graham W. Denton, Disinfection, Sterilization and Preservation, Lea & Febiger, Malver, Pennsylvania, 1991, Chapter 16, Chlorhexidene, p. 278-279. Results: The minimum inhibitory concentrations (MICs) of chlorhexidine gluconate are listed in parts per million (ppm). Numbers in parentheses refer to the number of strains evaluated. Microorganism MICs (ppm) Bacteria (Number of Strains) Micrococcus flavus (1) 0.5 Micrococcus lutea (1) 0.5 Staphylococcus aureus (16) 1-4 Staphylococcus epidermidis (41) 0.25-8 Streptococcus faecalis (5) 32-64 Streptococcus mutans (2) 2.5 Streptococcus pneumoniae (5) 8-16 Streptococcus pyogenes (9) 1-8 Streptococcus sanguis (3) 4-16 Streptococcus viridans (5) 2-32 Bacillus cereus (1) 8 Bacillus subtilis (2) 1 Clostridium difficile (7) 8-32 Clostridium welchii (5) 4-32 Corynebacterium sp. (8) 0.5-8 Lactobacillus casei (1) 128 Listeria monocytogenes (1) 4 Propionibacterium acne (2) 8 Acinetobacter anitratus (3) 16-64 Acinetobacter lwoffi (2) 0.5 Alcaligenes faecalis (1) 64 Bacteroides disastonis (4) 16 Bacteroides fragilis (11) 8-64 Campylobacter pyloridis (5) 8-32 Citrobacter freundii (10) 4-32 Enterobacter cloacae (12) 16-64 Escherichia coli (14) 2-32 Gardnerella vaginalis (1) 8 Haemophilus influenza (10) 2-8 Klebsiella aerogenes (5) 16-64 Klebsiella oxytoca (2) 32 Klebsiella pneumoniae (5) 32-128 Proteus mirabilis (5) 64->128 Proteus morganii (5) 16-128 10
PROVON Antimicrobial Skin Cleanser with 2% CHG (continued) Efficacy Data MICs (continued) Microorganism MICs (ppm) Bacteria (Number of Strains) Proteus vulgaris (5) 32-128 Providencia stuartii (5) 64-128 Pseudomonas aeruginosa (15) 16-32 Pseudomonas cepacia (1) 16 Pseudomonas fluorescens (1) 4 Salmonella bredeney (1) 16 Salmonella dublin (1) 4 Salmonella galinarum (1) 8 Salmonella montevideo (1) 8 Salmonella typhmurium (4) 8-16 Salmonella virchow (1) 8 Serratia marcescens (10) 16 Yeasts and Fungi MIC (ppm) Aspergillus flavus (1) 64 Aspergillus fumigatus (1) 32 Aspergillus niger (1) 16 Penicillium notatum (1) 16 Rhizopus sp. (1) 8 Scopulariopsis sp. (1) 8 Candida albicans (2) 9 Candida guillermondii (1) 4 Candida parapsilosis (2) 4 Candida pseudotropicalis (1) 3 Cryptococcus neoformans (1) 1 Prototheca zopfii (1) 6 Saccharomyces cerevissia (1) 1 Torulopsis glabrata (1) 6 Epidermophyton floccosum (1) 4 Microsporum canis (2) 4 Microsporum fulvum (1) 6 Microsporum gypseum (1) 6 Trichophyton equinum (1) 4 Trichophyton interdigitale (2) 3 Trichophyton mentagrophytes (1) 3 Trichophyton quinkeanum (1) 3 Trichophyton rubrum (2) 3 Trichophyton tonsurans (1) 3 Surgical Scrub Evaluation Objective: This evaluation measures the immediate and persistent antimicrobial effectiveness of the product and a reference product. Description of Test: Thirty-six (36) subjects were recruited and completed this evaluation. Baseline counts of the microbial skin flora of the hands of the subjects were performed utilizing a glove juice protocol. A standard surgical scrub wash was performed at least once by each of the subjects each day for five (5) days. A glove juice sampling procedure was performed at five (5) minutes post wash, three (3) hours post wash and six (6) hours post wash on days one (1), two (2) and five (5) after the first wash of the day. Additional scrubs without glove juice sampling occurred on days two (2), three (3) and four (4). Reference OTC TopicalAntimicrobial Products Tentative Final Monograph, Federal Register, Volume 43 (4): 1242-1243, 1978. Independent Laboratory: Skyland Scientific Services, Inc., Belgrade, MT. Conclusion: The results show good immediate and persistent antimicrobial effects of the product on the skin micro flora of the hands, in which the product was equivalent to or better than the reference product. Conclusion Chlorhexidine gluconate is very effective against both Gram-positive and Gramnegative bacteria, yeast and fungal microorganisms. Active Ingredient Chlorhexidine Gluconate (2% wt) Also Contains: Water Isopropyl Alcohol Surfactants Antimicrobial Surfactant, Cleaning 11
PROVON Antimicrobial Skin Cleanser with 2% CHG (continued) Results: Percent Reduction of Skin Micro Flora on the Hands 12
PROVON Medicated Lotion Soap with Chloroxylenol (PCMX) Stock No. 4201, 4202, 4203, 4206, 4208, 4520, 2102, 2202 Color: Clear, Light Amber : Fresh, Clean Balsam Viscosity: 3,000-7,000 cps ph: 8.6-9.2 Objective: Evaluation of skin irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: October 17, 1997 Results: Average score 0.09 (scale 0-4). Lower scores indicate low potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Efficacy Data In Vitro (continued) Microorganism ATCC No. % Reduction Escherichia coli (O157; H7) 35150 >99.999 Klebsiella pneumoniae 11296 >99.999 Listeria monocytogenes 7644 >99.999 Pseudomonas aeruginosa 15442 >99.999 Salmonella enteritidis 13076 >99.999 Salmonella typhimurium 14028 99.997 Shigella dysenteriae * 99.993 Shigella sonnei 11060 >99.999 Staphylococcus aureus (MRSA) 33591 99.014 Streptococcus pyogenes 19615 >99.999 * Clinical isolate Conclusion: Very effective reduction of Gram-negative and Gram-positive bacteria was demonstrated. Efficacy Data In Vitro Time-Exposure Kill Tests Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15)- or thirty (30)- second exposure kill studies were performed utilizing nineteen (19) challenge microorganisms. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: October 13, 1998 Percent Reduction of Test Organisms After a 15-Second Exposure Microorganism ATCC No. % Reduction Acinetobacter baumannii 19606 >99.999 Campylobacter jejuni 29428 >99.999 Citrobacter freundii 8090 >98.554 Clostridium difficile 9689 >99.999 Clostridium perfringens 13124 >99.999 Enterococcus faecalis Vancomycin resistant 51575 99.866 Enterococcus faecium Vancomycin resistant 51559 99.954 Escherichia coli 11229 >99.999 Active Ingredient Chloroxylenol 0.3% Also Contains: Coconut Acid Oleic Acid Sodium Sulfate Ethanolamine Coco-Betaine Aloe Barbadensis Leaf Juice Cocamide MEA Hydrolyzed Vegetable Protein Hydroxypropyl Methylcellulose Propylene Glycol Retinyl Palmitate Tetrasodium EDTA Tocopheryl Acetate Zea Mays (Corn) Oil (Parfum) Antimicrobial Cleansing Cleansing Viscosity Increasing Cleansing Botanical Additive, Skin Conditioning Foam Booster, Viscositiy Increasing Skin Conditioning Viscosity Increasing Skin Conditioning, Skin Conditioning Chelating Skin Conditioning Skin Conditioning 13
PROVON Medicated Lotion Soap with Triclosan Stock No. 4152, 4153, 2258, 2158 Color: Clear, Light Amber : Fresh, Clean Balsam Viscosity: 2,700-15,300 cps ph: 7.0-10.0 Objective: Evaluation of skin irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: June 19, 1998 Results: Average score 0.12 (scale 0-4). Lower scores indicate low potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Efficacy Data In Vitro Timed-Exposure Kill Tests Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Fifteen (15) or thirty (30)- second-exposure kill studies were performed utilizing nineteen (19) challenge bacteria. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (15 seconds or 30 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana. Date: October 13, 1998 Percent Reduction of Test Organisms After a 15-Second Exposure Microorganism ATCC No. % Reduction Acinetobacter baumannii 19606 >99.999 Campylobacter jejuni 29428 >99.999 Citrobacter freundii 8090 >96.436* Clostridium difficile 9689 >99.999 Clostridium perfringens 13124 >99.999 Enterococcus faecalis Vancomycin resistant 51575 >99.988 Enterococcus faecium Vancomycin resistant 51559 >99.987 Escherichia coli 11229 >99.999 Escherichia coli (O157; H7) 35150 >99.97 Klebsiella pneumoniae 11296 >99.999 Listeria monocytogenes 7644 >99.999 Proteus mirabilis 7002 >95.640* Pseudomonas aeruginosa 15442 >99.999 Salmonella enteritidis 13076 >99.999 Efficacy Data In Vitro (continued) Microorganism ATCC No. % Reduction Salmonella typhimurium 14028 >99.998 Shigella dysenteriae ** 99.996 Shigella sonnei 11060 99.999 Staphylococcus aureus Methicillin resistsant 33591 99.702 Streptococcus pyogenes 19615 >99.999 * 30-Second Exposure ** Clinical isolate Conclusion: Very effective reduction of Gramnegative and Gram-positive bacteria by the product was demonstrated. Active Ingredient Triclosan 0.3% Also Contains: Coconut Acid Sodium Sulfate Oleic Acid Ethanolamine Coco-Betaine Aloe Barbadensis Leaf Juice Cocamide MEA Hydrolyzed Vegetable Protein Hydroxypropyl Methylcellulose Propylene Glycol Retinyl Palmitate Tetrasodium EDTA Tocopheryl Acetate Zea Mays (Corn) Oil (Parfum) Methylchloroisothiazolinone Methylisothiazolinone Antimicrobial Cleansing Viscosity Increasing Cleansing Cleansing, Skin Conditioning, Foam Booster Botanical Additive, Skin Conditioning Foam Booster, Viscositiy Increasing Viscosity Increasing, Chelating 14
PROVON Antimicrobial Lotion Soap with 0.3% Chloroxylenol Stock No. 4212, 4213, 4216, 4218, 4555, 2218, 2118 Color: Clear Amber : Fresh Citrus Viscosity: 2,700-15,300 cps ph: 7.0-10.0 Objective: Evaluation of skin irritation potential in humans. Description of Test: 21-Day Cumulative Irritancy Assay with Delayed Challenge. Date: October 17, 1997 Results: Average score 0.28 (scale 0 4); no sensitization occured. Conclusion: The product has a low potential for skin irritation and allergic contact dermatitis. Efficacy Data In Vitro Objective: Evaluation of the antimicrobial effectiveness of the product in vitro. Description of Test: Thirty (30)-second-exposure kill studies were performed utilizing eighteen(18) challenge bacterial strains. The challenge inoculum was introduced to the test product at time zero; a portion of the sample was removed and placed in neutralizing media at the appropriate time (30 seconds). Standard plate counting techniques were used to enumerate viable challenge microorganisms. Independent Laboratory: BioScience Laboratories, Inc., Bozeman, Montana Date: April, 2001 Active Ingredient Chloroxylenol 0.3% Also Contains: Coconut Acid Oleic Acid Sodium Sulfate Ethanolamine Cocamide DEA Sodium Laureth Sulfate Sodium Lauryl Sulfate Aloe Barbadensis Leaf Juice Propylene Glycol Soyamidopropyl Betaine Tetrasodium EDTA Tocopheryl Acetate Hydroxypropyl Methylcellulose Sodium Chloride (Parfum) Triclosan Blue No. 1 (CI 42090) Red No. 4 (CI 14700) Red No. 33 (CI 17200) Yellow No. 5 (CI 19140) Antimicrobial Cleansing Cleansing Viscosity Increasing Surfactant, Foam Booster Viscosity Increasing Surfactant, Cleansing Surfactant, Cleansing Botanical Additive, Skin Conditioning, Cleansing, Viscosity Increasing Chelating Viscosity Increasing Viscosity Increasing Percent Reduction of Test Organisms After a 30-Second Exposure Microorganism ATCC No. % Reduction Citrobacter freundii 8090 >99.999 Enterococcus faecalis Multi-drug resistant 51575 >99.991 Enterococcus faecium Multi-drug resistant 51559 >99.992 Staphylococcus aureus Methicillin resistant 33591 >97.576 Staphylococcus epidermidis 12228 >98.253 * 30-Second Exposure Conclusion: Effective reduction of Gram-negative and Gram-positive bacteria was demonstrated 15
PROVON Gentle Lotion Soap Stock No. 4222, 4223, 4226, 4228, 2219, 2119 Color: Light Yellow : Fresh, Clean Viscosity: 2,700-15,300 cps ph: 7.0-10.0 Objective: Evaluation of irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: July 18, 1997 Results: Average score 0.09 (scale 0-4). Lower scores indicate lower potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. PROVON Mild Lotion Soap Stock No. 4008, 4019, 2208, 2108, 4508 Color: Blue Pearl : Fresh, Clean Viscosity: 2,700-15,300 cps ph: 7.0-10.0 Objective: Evaluation of irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: May 7, 1993 Results: Average score 0.23 (scale 0-4). Lower scores indicate lower potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Contents Water Cocamidopropyl Betaine Coconut Acid Oleic Acid Sodium Sulfate Ethanolamine Aloe Barbadensis Leaf Juice Cocamide DEA Hydrolyzed Vegetable Protein Polystyrene Propylene glycol Retinyl Palmitate Tetrasodium EDTA Tocopheryl Acetate Zea Mays (Corn) Oil Hydroxypropyl Methylcellulose (Parfum) Chloroxylenol Cleansing, Skin Conditioning Cleansing Cleansing Viscosity Increasing Botanical Additive, Skin Conditioning Surfactant, Foam Booster Opacifier, Chelating Viscosity Increasing Contents Coconut Acid Oleic Acid Sodium Sulfate Ethanolamine Cocamide DEA Cocamidopropyl Betaine Glycol Distearate Lauramide DEA Propylene Glycol Sodium Laureth Sulfate Tetrasodium EDTA (Parfum) Chloroxylenol Blue No. 1 (CI 42090) Cleansing Cleansing Viscosity Increasing Surfactant, Foam Booster Cleansing Pearlizing, Emollient Viscosity Increasing, Surfactant, Cleansing Chelating 16
PROVON Enriched Lotion Cleanser Stock No.2213, 2113, 4013, 4017 Color: Pink, pearled : Floral Viscosity: 3,700-20,000 cps ph: 4.5-9.5 Objective: Evaluation of irritation potential in humans. Description of Test: 21-Day Human Irritancy Assay with Delayed Challenge. Date: November 9, 2001 Results: Average score 0.14 (scale 0-4). Lower scores indicate lower potential for skin irritation and allergic contact dermatitis. Conclusion: Product has a low potential for skin irritation and allergic contact dermatitis. Contents Sodium Laureth Sulfate Cocamide DEA Sodium Lauryl Sulfate Ammonium Chloride Disodium Laureth Sulfosuccinate Aloe Barbadensis Leaf Juice Cocamide MEA Cocamidopropyl PG-Dimonium Chloride Phosphate Glycerin Glycol Distearate Lactic Acid Laureth-7 Retinyl Palmitate Simmondsia Chinensis (Jojoba) Seed Oil Sodium C14-16 Olefin Sulfonate Soyamidopropyl Betaine Tocopheryl Acetate Zea Mays (Corn) Oil Sodium Chloride (Parfum) DMDM Hydantoin Red 33 (CI 17200) Surfactant, Cleansing Surfactant, Foam Booster, Viscosity Increasing Surfactant, Cleansing Viscosity Increasing Surfactant, Cleansing, Foam Booster Botanical Additive, Skin Conditioning Foam Booster, Viscosity Increasing, Pearlizing, Emollient Surfactant Surfactant, Cleansing Cleansing, Viscosity Increasing Viscosity Increasing PROVON Foaming Handwash with Moisturizers Stock No. 5285, 5185, 5985 Color: Clear Pink : Cranberry Form: Liquid ph: 4.5-9.5 Objective: Evaluation of skin irritation potential in humans. Description of Test: Phillips et al (Toxic and Applied Pharmacology 21: 369-382) summarizes the method utilized for this evaluation. Fresh materials are applied daily, 5 days per week, for 21 days to the same site (patches were not moved or reapplied on the weekends). Date: July 5, 2002 Results: Average score = 0.16 (scale 0-4); No sensitization occurred. Conclusion: The product has a low potential for skin irritation and allergic contact dermatitis. Human Repeated Insult Patch Test Objective: Determination of the dermal irritation and sensitization potential of the product. Description of Test: Human repeated insult patch test. Independent Laboratory: Clinical Research Laboratories, Inc., Piscataway, N.J. Date: February 25, 2003 Results: No visible skin reactions were observed during the induction or challenge phases of the study. Conclusions: Test product demonstrated no potential for eliciting either dermal irritation or sensitization. 17