March 01, 2010 Dear Customer, Thank you for your recent inquiry into PURELL Waterless Surgical Scrub. PURELL is an effective surgical scrub formulation that meets the requirements of the surgical scrub as outlined in the United States Food and Drug Administration s (FDA) Topical Antimicrobial Drug Products for Human use; Tentative Final Monograph for Health Care Antiseptic Drug Products (Federal Register, Vol. 59, No. 116, Friday, June 17, 1994). We understand that a competitor has raised the following issues which we will address in this letter. 1. CHG is the standard for surgical scrub antisepsis by the FDA 2. How can a product with only alcohol have the same persistence and cumulative activity as CHG? 3. Per FDA, inactive ingredients cannot contribute to claimed effects 4. Preservative free 5. FDA/NDA approval which includes a complete review by FDA 6. AORN Recommended Practices for Surgical Hand Antisepsis/Hand Scrubs CHG is the standard for surgical scrub antisepsis by the FDA Traditional surgical scrub products utilize chlorhexidine gluconate (CHG) as the active ingredient and early alcohol based surgical scrubs utilize CHG as a secondary active in order to meet the antimicrobial efficacy requirements outlined in the monograph. The monograph calls for meeting immediate kill requirements and maintaining a level less than baseline after six hours in a glove. Developing an alcohol based surgical scrub with alcohol as the single active was a challenging development and we are proud to have a product that does not require a second active to meet the six hour persistence criteria. How can a product with only alcohol have the same persistence and cumulative activity as CHG? Below is a scientific explanation that addresses the antimicrobial efficacy and persistence activity of PURELL Waterless Surgical Scrub: Alcohol is widely accepted for its rapid bactericidal ( fast kill ) properties and typically outperforms other antimicrobials including CHG. Because alcohol rapidly evaporates from the skin, a common misperception is that fast kill is the only means by which alcohol performs. However scientific publications have demonstrated that re-growth of alcohol exposed bacteria is slowed due to sub-lethal injury caused by the alcohol. We deem that the persistent activity of PURELL Waterless Surgical Scrub is achieved through sub-lethal damage to the pathogens caused by the alcohol. Some of those damaged pathogens may recover while others that have been injured will die. We refer to this property as slow kill. The excipients (inactive ingredients) we have chosen for the PURELL Waterless Surgical Scrub result in a low ph which potentiates (improves) the slow kill process. The lower ph of PURELL Waterless Surgical Scrub creates a hostile environment inhibiting the regrowth or repopulation of bacteria on the skin. This patent pending technology is what makes PURELL Waterless Surgical Scrub unique.
Per FDA, inactive ingredients cannot contribute to claimed effects We make no claims of antimicrobial efficacy with the inactive ingredients in PURELL Waterless Surgical Scrub. Inactive ingredients are there to provide cosmetic benefits such as moisturization, easy application, easy gloving and overall product stability without negatively affecting the efficacy and persistence of the active ingredient. Preservative free The FDA allows products to be manufactured with preservatives and requires that the product is fit for use through the shelf life of the product. Due to the alcohol content in PURELL Waterless Surgical Scrub, preservatives are not required for this formulation. It does contain the preservatives Methylchloroisothiazolinone and Methylisothiazolinone which are components of a raw material prior to formula manufacturing. The ingredients are below preservative levels in the finished product. GOJO elects to include them in the inactive ingredient listing to provide full information. FDA/NDA approval which includes a complete review by FDA FDA has two routes for marketing of healthcare antiseptic skin products including surgical scrubs. For active ingredients where sufficient information is available to determine the safety and efficacy of the product, the FDA issues monographs allowing companies to market products in compliance with the monograph without prior approval. Alcohol is recognized in the Healthcare Antiseptic Tentative Final Monograph as safe and effective for surgical scrubs at 60-95% alcohol. FDA requires full review and prior approval for active ingredients that are not recognized as safe and effective through the monograph. CHG is not part of the monograph and requires pre-approval through the New Drug Application (NDA) process. AORN Recommended Practices for Surgical Hand Antisepsis/Hand Scrubs An FDA-compliant, surgical hand antiseptic agent (i.e., surgical hand scrub/ rub) approved by the facility s infection control personnel should be used for all surgical hand antisepsis/ hand scrubs. The surgical hand antiseptic agent should significantly reduce microorganisms on intact skin; contain a non-irritating, antimicrobial preparation; be broad spectrum; be fast acting; and have a persistent effect 1. If the alcohol-based product is selected, the product should meet FDA regulatory requirements as out-lined in the Tentative Final Monograph (TFM) for Health-care Antiseptic Drug Products or be the subject of a new drug approval (NDA). The FDA requires that products provide a one-log reduction on day one, a two-log reduction on day two, a three-log reduction on day five, and show persistent activity for at least six hours on each of the three test days. Enclosed with this letter are the technical bulletins supporting the efficacy and persistence activity of PURELL Waterless Surgical Scrub compared to a CHG control product. Please feel free to contact us if you have any further questions or comments at 1-800-321-9647. Sincerely,
Dave Mackay Vice President Sales and Marketing - Healthcare Footnote: 1 Association of perioperative Registered Nurses (2010). Perioperative Standards and Recommended Practices. Recommended Practices for Hand Hygiene in the Perioperative Setting. Appendix attached: see additional information below.
Appendix A: Information contrasting PURELL Instant Hand Sanitizer with PURELL Waterless Surgical Scrub PURELL Instant Hand Sanitizer and PURELL Waterless Surgical Scrub are Over-The-Counter (OTC) drug products in the United States and are regulated by the United States Food and Drug Administration (FDA). They are regulated under the FDA Topical Antimicrobial Drug Products for Human use; Tentative Final Monograph for Health Care Antiseptic Drug Products (Federal Register, Vol. 59, No. 116, Friday, June 17, 1994). Testing Differences In order to label a product as a surgical scrub, extensive testing is required by the FDA to demonstrate that the product sufficiently reduces the level of bacteria on the skin and that the bacterial count remains below baseline levels for six hours. This is to simulate glove use during surgery. PURELL Waterless Surgical Scrub meets these stringent criteria for efficacy. The ability to meet this test is dependent on the active ingredient and the synergy of the active ingredient within a specific formulation. During development, we explored multiple prototypes of alcohol based products across a range of active levels and with various excipients to find the right balance to meet the rigid surgical scrub efficacy criteria and the aesthetics to achieve positive results in skin feel, ease of gloving following use, and a mild product with a low potential for skin irritation. Our patent pending technology provides that balance of user needs while providing the efficacy required for a surgical scrub. PURELL Instant Hand Sanitizer is effective across a wide range of bacteria and its primary purpose is to destroy transient bacteria obtained on the hands during routine medical care. It has not been formulated to meet the needs of a surgical product where hands are encased in gloves for extended periods. It meets the criteria for routine hand decontamination when hands are not visibly soiled as outlined in the 2002 CDC Hand Hygiene Guideline. Its effectiveness has been demonstrated in outcome studies across healthcare, military, education and workplace environments. Labeling Differences Based on the FDA monograph, GOJO markets the products with different labeling information. The table below identifies differences between the two products. PURELL Instant Hand Sanitizer PURELL Waterless Surgical Scrub Active Ingredient 62% ethyl alcohol 70% ethyl alcohol Purpose Antimicrobial Surgical Scrub Indications for Use Hand sanitizer to help reduce bacteria on the skin Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
PURELL Instant Hand Sanitizer Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised when using this product. PURELL Waterless Surgical Scrub clean under the nails with a nail pick nails should be no more than one quarter inch (0.64cm) long according AORN standards Dispense 2 ml of product into the palm of your right hand Dip fingertips of left hand into the product and work under nails. Spread remaining product evenly over your left hand and forearm Pay attention to all skin surfaces including the nails, cuticles and web area in between fingers. Repeat steps for the opposite hand and arm allow to air dry completely.