$ 10 Mail-In Rebate This rebate is provided to help with the cost of your medication. Look forward to clearer skin and a $10.00 refund on your next MetroGel 1% prescription. Just send in this coupon with your pharmacy receipt and we ll send you a check for $10.00. This rebate may not be reproduced without written consent. See reverse side for redemption information. Please allow 3 to 4 weeks for delivery. Rebate offer valid until 12/31/06. My physician s instructions: Cleanse Medicate Moisturize Protect Other $10 mail-in rebate inside What you should know about ROSACEA. Please allow 3 to 4 weeks for delivery. 2005 Galderma Laboratories www.bestfaceforward.com L.P. Tri-Luma and Galderma are registered trademarks. This offer may not be reproduced without written consent. www.metrogel.com Visit us online at: www.metrogel.com www.bestfaceforward.com DERMATOLOGISTS RECOMMEND CETAPHIL CLEANSERS AND MOISTURIZERS $1 00 off any Cetaphil product MANUFACTURER S COUPON EXPIRES 12/31/06 join the cetaphil skin care club www.mycetaphil.com MetroGel Cetaphil and Galderma are registered trademarks. HSA-3 is a trademark of Galderma. 2006 Galderma Laboratories L.P. Galderma Laboratories L.P. 14501 N. Freeway Fort Worth TX 76177 MET-558 Printed in USA 12/05
www.metrogel.com What is rosacea? Rosacea (pronounced rose-ay-shah) is a condition that mostly affects the skin of the face usually in the area where people blush. There are a number of symptoms ranging from mild to more severe as you will see from the following list: Pimples As a result of continual flushing the skin eventually becomes irritated and inflamed and pimples may appear on the face. These pimples may be papules (small red and solid) or pustules (pus-filled like teenage acne). Broken or enlarged blood vessels Doctors call this telangiectasia (tell-an-jek-tazeyah). When people with rosacea flush the small blood vessels of the face get larger eventually showing through the skin. They may appear as spots or as thin wavy lines. 2 Redness This can look like nothing more than a blush or a sunburn. It s caused by flushing (when a large amount of blood rushes to the blood vessels just under the skin and the vessels expand to handle the flow). Over time the redness does not go away. 3
Rosacea is a chronic condition which means the symptoms may come and go in cycles and fluctuate in their degree of severity. Many people mistake their rosacea for things like sunburn windburn a complexion change or acne and don t bother to see a doctor. However the earlier you see a dermatologist the quicker your rosacea can be brought under control. Enlarged bumpy nose This condition is called rhinophyma (rhy-no-fye-muh) and is present in the more advanced stages of rosacea especially in men. When rosacea isn t treated early small knobby bumps may gradually appear on the nose giving it a swollen appearance. to severe to severe How does it start and how does it progress? The first sign of rosacea is usually rosy cheeks. As it progresses the face may get red in patches and stay red for hours or days at a time and eventually the redness doesn t go away at all. Who gets rosacea? Rosacea is usually seen in adults. It can affect those in their 30s to people in their 70s and 80s as well as people of all skin colors and skin types. Most people who get rosacea seem to flush or blush more often than the average person and may have parents or grandparents who have the same symptoms. Treatment Beginning treatment usually consists of an oral and a topical medication. You may see results in the first few weeks although full results usually take up to 12 weeks. Although 85% of patients with rosacea stop using their medication after 3 months a clinical study showed that nearly one fourth of patients relapsed within the first few days. Sixty percent relapsed within the first 6 months. That s why this incurable chronic condition requires ongoing control. 4 5
www.bestfaceforward.com Topical medication Your dermatologist will recommend the right care for your symptoms. One medication that may be prescribed for you is the newest prescription product available for rosacea called MetroGel 1%. It s the most powerful strength of metronidazole you can get. Its exclusive formulation contains HSA-3 a combination of ingredients including betadex niacinamide (vitamin B 3 ) and propylene glycol. In a 92% water-based gel these ingredients work together to help moisturize your skin while enhancing the absorption of the medicine. The result is a smooth silky texture that feels gentle on your face. MetroGel 1% is also convenient. You need to use it just once a day so it s easy to remember and the smooth gel formulation makes it easy to apply. MetroGel 1% contains no alcohol to dry your skin the way other products can. And even though some products have ingredients that can damage the outer layer of your tender skin MetroGel 1% has been proven to not damage the outer layer of skin and to not cause the skin to lose moisture. For more information about MetroGel 1% visit www.metrogel.com. The following adverse experiences have been reported with the topical use of metronidazole: burning skin irritation dryness transient redness metallic taste tingling or numbness of extremities and nausea. Before treatment Oral medication Capsules or tablets are taken by mouth usually once or twice a day. Some of these may have special treatment instructions so ask your doctor or pharmacist about them. A clinical study showed that patients who used both an oral antibiotic and a topical metronidazole-based medication were able to effectively control their rosacea. After 5 weeks with MetroGel 1% 6 Please see brief summary of Prescribing Information on pages 14 and 15. 7
Daily care Following a regular cleansing and medication routine once a day or as prescribed by your doctor will make treatment easier and more successful. How and what you use to cleanse and moisturize your face is also important. Here are some simple steps to follow: Step 1: Cleanse gently with a very mild cleanser. Avoid products that contain alcohol or other irritants. Dermatologists often recommend Cetaphil Gentle Skin Cleanser a gentle soapless product available at most drugstores. It does an excellent job of cleaning without irritating. Makeup While you are in the process of getting your symptoms under control and afterwards makeup can help hide your rosacea. Oil-free foundations with yellow (not pink) undertones are recommended as are special green-tone products specifically designed to be worn under foundation to disguise facial redness. Yellowtone cover-ups are available from many brands. Step 2: Medicate according to your dermatologist s instructions. Step 3: Moisturize with a good-quality noncomedogenic (meaning it won t clog pores) moisturizer as needed. If your treatment includes a topical medication you can usually apply the moisturizer after the medication has dried. The Cetaphil product line also includes a moisturizer available in both lotion and cream forms that is specially designed for sensitive skin. In addition MetroGel 1% with HSA-3 has an exclusive combination of ingredients that moisturizes your skin while delivering effective medicine. Step 4: Protect with a sunscreen of SPF 15 or higher even on cloudy days. Look for a noncomedogenic product that does not contain alcohol. Cetaphil Daily Facial Moisturizer with SPF 15 is an excellent choice. Maintenance Since rosacea can t be cured once your symptoms have cleared up you will need to continue using your MetroGel 1% daily to keep your clearer healthier look. Without this regular therapy your symptoms may return and possibly get worse over time. Keeping your skin clear will take some dedication on your part. Once you have started to enjoy the results adding treatment with MetroGel 1% to your daily routine won t seem like any problem at all. Also be sure to refill your prescription regularly so you can continue your therapy and maintain your good results. 8 Please see brief summary of Prescribing Information on pages 14 and 15. 9
www.metrogel.com Avoid rosacea triggers The chart to the right provides a list of things that can aggravate your rosacea symptoms. It is unlikely that you will react to them all but by being observant you can discover which ones apply to you and help avoid future flare-ups. You may need to experiment to determine all of your own personal triggers. You may find it helpful to keep a daily diary of your food consumption and activities to get a better idea of what causes your episodes of flushing. Once you have identified your own triggers try staying away from them for a few days. If you notice a reduction in the frequency and severity of your flare-ups you have probably identified what you should avoid to help keep your rosacea under control. A conversation with all of your doctors in addition to your dermatologist may also be in order especially if they have prescribed medication for any other medical conditions you may have. Weather Sun Cold Emotional influences Stress Temperature-related Physical exertion Exercise Strong winds Humidity Anxiety Saunas and hot baths Simple overheating Excessively warm environments Skin care products Beverages Lift and load jobs Some cosmetics and hair sprays especially those containing alcohol witch hazel or fragrances Topical steroids Any substance that causes redness or stinging Alcohol especially red wine beer bourbon gin vodka or champagne Hot drinks including hot cider hot chocolate coffee or tea Foods Liver Chocolate or vanilla Soy sauce and vinegars Vegetables including eggplant spinach lima and navy beans and peas Dairy products including yogurt sour cream and some cheeses Fruits including avocados tomatoes bananas red plums raisins figs and citrus fruits Hot and spicy foods 10 11
THE PROGRAM A complimentary educational program to help you live better with rosacea Best Face Forward is a free program created with the advice and input of dermatologists and their patients with rosacea. You re eligible to enroll at no cost and receive all the information and money-saving coupons it offers. The Best Face Forward Program includes: Informative newsletters about rosacea with medical news practical advice cosmetic tips and personal stories from people with rosacea Money-saving coupons rebates and special offers 3 ways you can enroll today in the Best Face Forward Program Visit www.bestfaceforward.com Visit www.metrogel.com Fill out attached reply card and mail Through your newsletter I ve learned how to care for my skin. And knowing names of helpful products saves me time and trying to figure it out on my own. Flora B. Kenner LA Finally keeping my rosacea under control makes a world of difference in how I look and feel every day. Maureen B. Avon CT Before using MetroGel my face stayed so red bumpy and itchy. I just love the feel of my face now it s so soft and feels great. Judy F. Beckley WV 12 13
BRIEF SUMMARY Rx Only For topical use only. Not for oral ophthalmic or intravaginal use. INDICATIONS AND USAGE METROGEL (metronidazole gel) 1% is indicated for the topical treatment of inflammatory lesions of rosacea. CONTRAINDICATIONS METROGEL (metronidazole gel) 1% is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. PRECAUTIONS General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore contact with the eyes should be avoided. If a reaction suggesting local skin irritation occurs patients should be directed to use the medication less often or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of or history of blood dyscrasia. Information for Patients: Patients using METROGEL (metronidazole gel) 1% should receive the following information and instructions: 1. This medication is to be used as directed. 2. It is for external use only. 3. Avoid contact with the eyes. 4. Cleanse affected area(s) before applying METROGEL (metronidazole gel) 1%. 5. This medication should not be used for any other condition than that for which it is prescribed. 6. Patients should report any adverse reaction to their physicians. Drug Interaction: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL (metronidazole gel) 1% is prescribed for patients who are receiving anticoagulant treatment although they are less likely to occur with topical metronidazole administration because of low absorption. Carcinogenesis Mutagenesis and Impairment of Fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic oral administration in mice and rats but not in studies involving hamsters. In several long-term studies in mice oral doses of approximately 225 mg/m 2 /day or greater (approximately 37 times the human topical dose on a mg/m 2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m 2 /day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However in another study no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn s disease treated with the drug for 8 months. In one published study using albino hairless mice intraperitoneal administration of metronidazole at a dose of 45 mg/m 2 /day (approximately 7 times the human topical dose on a mg/m 2 basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL (metronidazole gel) 1% or any marketed metronidazole formulations. Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL (metronidazole gel) 1% in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times respectively the expected clinical dose. However oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response METROGEL (metronidazole gel) 1% should be used during pregnancy only if clearly needed. Nursing Mothers: After oral administration metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother and the risk to the infant. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: While specific clinical trials in the geriatric population have not been conducted sixty-six patients aged 65 years and older treated with METROGEL (metronidazole gel) 1% over ten weeks showed comparable safety and efficacy as compared to the general study population. ADVERSE REACTIONS In a controlled clinical trial 557 patients used METROGEL (metronidazole gel) 1% and 189 patients used the gel vehicle once daily. The following table summarizes adverse reactions that occur at a rate of >1% in the clinical trials: System Organ Class/Preferred Term Patients with at least one AE (Number % of patients) Infections and infestations Bronchitis Influenza Nasopharyngitis Sinusitis Upper respiratory tract infection Urinary tract infection Vaginal mycosis Musculoskeletal and connective tissue disorders Back pain Neoplasms Basal cell carcinoma Nervous system disorders Headache Respiratory thoracic and mediastinal disorders Nasal congestion Skin and subcutaneous tissue disorders Contact dermatitis Dry skin Vascular disorders Hypertension Metronidazole Gel 1% N=557 186 (33.4) 76 (13.6) 8 (1.4) 17 (3.1) 8 (1.4) 14 (2.5) 1 (0.2) 19 (3.4) 3 (0.5) 4 (0.7) 1 (0.2) 18 (3.2) 12 (2.2) 22 (3.9) 36 (6.5) 7 (1.3) 8 (1.4) Gel Vehicle N=189 51 (27.0) 28 (14.8) 8 (4.2) 4 (2.1) 5 (2.6) 5 (2.6) 12 (6.3) The following table summarizes the highest scores of local cutaneous signs and symptoms of irritation that were worse than baseline: Sign/Symptom Dryness Severe Scaling Severe Pruritus Severe Stinging/burning Severe Metronidazole Gel 1% N=544 138 (25.4) 93 (17.1) 42 (7.7) 3 (0.6) 134 (24.6) 88 (16.2) 43 (7.9) 3 (0.6) 86 (15.8) 53 (9.7) 27 (5.0) 56 (10.3) 39 (7.2) 7 (1.3) 10 (1.8) Gel Vehicle N=184 63 (34.2) 41 (22.3) 20 (10.9) 60 (32.6) 32 (17.4) 27 (14.7) 35 (19.0) 21 (11.4) 13 (7.1) 28 (15.2) 18 (9.8) 9 (4.9) The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation transient redness metallic taste tingling or numbness of extremities and nausea. OVERDOSAGE: There are no reported human experiences with overdosage of METROGEL (metronidazole gel) 1%. Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects. DOSAGE AND ADMINISTRATION: Areas to be treated should be cleansed before application of METROGEL (metronidazole gel) 1%. Apply and rub in a thin film of METROGEL (metronidazole gel) 1% once daily to entire affected area(s). Patients may use cosmetics after application of METROGEL (metronidazole gel) 1%. HOW SUPPLIED: METROGEL (metronidazole gel) 1% is available in a 45-gram tube. 45 gram tube NDC 0299-3820-45 Keep out of the reach of children. Storage Conditions: Store at controlled room temperature: 20 to 25 C (68 to 77 F) excursions permitted between 59 and 86 F (15-30 C). Prescribing Information as of June 2005. Rx Only US Patent No. 6881726 Marketed by: Manufactured by: Galderma Laboratories L.P. Galderma Production Canada Inc. Fort Worth Texas 76177 USA Montreal QC H9X 3N7 Canada P50696-0 0705 Made in Canada. www.metrogel.com Submit: Send to: Receive: MetroGel (metronidazole gel) 1% Mail-In Rebate Offer This rebate certificate along with your dated pharmacy receipt. Circle purchase price and prescription number on receipt. Galderma Laboratories L.P. c/o Beechwood Associates Inc. P.O. Box 1190 Morrisville NC 27560 $10.00 refund check Rebates are not valid for prescriptions reimbursed under a federally funded health care program including Medicare or Medicaid as well as similar state programs including any state medical assistance programs. Offer void where prohibited by law taxed or restricted. Offer good only in USA. Void in Minnesota Massachusetts Michigan and Rhode Island except for prescriptions that are not reimbursed by any thirdparty payer. Manufacturer reserves the right to rescind revoke or amend this offer without notice. By my signature below I certify that I am not being reimbursed for this product by Medicare or Medicaid any other federal or state program including any state pharmaceutical assistance program or any other thirdparty payers. I also understand that I am responsible for any reporting or other requirements with respect to receipt of this rebate. Name (please print) Address City State ZIP E-mail Physician s name Please enroll me in the free Best Face Forward program so I can receive offers and information about rosacea. Please do not enroll me in the Best Face Forward Program. I have complied with all the terms of this offer. Signature (must be signed in order to be valid) MetroGel and Galderma are registered trademarks. 2006 Galderma Laboratories L.P. Galderma Laboratories L.P. 14501 N. Freeway Fort Worth TX 76177 MET-558 Printed in USA 12/05 Save $ 1.00 on Cetaphil cleansers or moisturizers (any size) CONSUMER: Limit one coupon per item purchased. This coupon good only on product indicated. DEALER: We will reimburse you face value plus 8 if submitted in compliance with Galderma Laboratories Manufacturer s Coupon Redemption Policy dated 10/92 available upon request. Consumer must pay sales tax. Good only in USA. Send coupons to Galderma Laboratories L.P. CMS Department 00020 1 Fawcett Drive Del Rio TX 78840. Cash value 1/20. Void where prohibited or restricted. 60729 Cetaphil and Galderma are registered trademarks. 2006 Galderma Laboratories L.P. 14 15 5 00299 31076 2 (8100)3 60729 MANUFACTURER S COUPON EXPIRES 12/31/06