ACNE THERAPY. Date: January 26, 2016 FOREWORD

Transcription

1 ACNE THERAPY Date: January 26, 2016 FOREWORD This monograph describes the requirements necessary to receive marketing authorization (a Natural Product Number (NPN) or a Drug Identification Number (DIN)) for a product intended to treat/manage acne. Acne therapy products are classified as natural health products (NHPs) if they contain an ingredient listed in Table 1 and do not contain any ingredient listed in Table 2. Applicants seeking to obtain a NPN can access the appropriate forms and guidance at Acne therapy products are classified as drugs if they contain an ingredient listed in Table 2. Applicants seeking to obtain a DIN can access the appropriate forms and guidance at Note: The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Text in parentheses is additional optional information which can be included on the Product Licence Application form and label at the applicant s discretion. Medicinal Ingredient(s) Table 1: NHP medicinal ingredients and associated doses Proper name(s) 1 Common name(s) 1 Source material(s) 2 Quantity 3 Salicylic acid Salicylic acid Salicylic acid 0.5-2% 2-Hydroxybenzoic acid CAS No Sulfur Sulfur Sulfur 3-10% 4 CAS No ,3-Benzenediol Resorcinol Resorcinol 2% Resorcinol CAS No ,3-Benzenediol, monoacetate Resorcinol monoacetate Resorcinol monoacetate Resorcinol monoacetate CAS No % 1 At least one of the following references was consulted: O Neil et al. The Merck Index Online 2015; USP 38 2 At least one of the following references was consulted: O Neil et al. The Merck Index Online 2015; USP 38 3 FDA Final Rule 2010; 21 CFR part 333 Topical Antimicrobial Drug Products for Over-The-Counter Human use 4 The appropriate dosage range for sulfur in combination with resorcinol or resorcinol monoacetate is 3-8 % (FDA 2010)

2 * Resorcinol and Resorcinol monoacetate are not permitted as single medicinal ingredients and must be in combination with 3-8 % sulfur (FDA 2010). Table 2: Drug medicinal ingredient Medicinal ingredient preferred name Quantity Benzoyl peroxide 2.5-5% Permitted Combinations of Medicinal Ingredients The only permitted combinations are sulfur + resorcinol or resorcinol monoacetate (FDA 2010): Sulfur: 3-8 % + Resorcinol: 2 % Sulfur: 3-8 % + Resorcinol monoacetate: 3 % Additional notes: Products containing resorcinol or resorcinol monoacetate in combination with sulfur cannot be indicated as body cleansers or as a face wash. Route of administration Topical Dosage form(s) 5 Acceptable dosage forms include: Lotion, cream, gel, solution, liquid, ointment, wipe, aerosol and paste. Use(s) or Purpose(s) 6 Statement(s) to the effect of: For all products: For the treatment/management of acne. Helps treat acne pimples (Optional: and allow skin to heal ). Dries and helps clear up acne pimples (Optional: and allow skin to heal ). Reduces the number and/or severity of acne pimples (Optional: and allow skin to heal ). Penetrates pores to help control (reduce) acne pimples. Helps keep skin clear of new acne pimples. 5 Consult Appendix 1 for dosage forms that fall outside the scope of the monograph. 6 Consult Appendix 2 for uses or purposes that fall outside the scope of the monograph. Acne Therapy - Page 2 of 10

3 Helps prevent new acne pimples from forming. For products containing benzoyl peroxide, the following statement may be made: Prevents and kills acne bacteria. Unacceptable use(s) or purpose(s): Statement(s) to the effect of: Controls oil (oily skin). Cures acne. Directions for use Statement(s) to the effect of: For all products: Cleanse skin thoroughly before applying the product. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily, if needed, or as directed by a health care professional. If excessive dryness or peeling occurs, reduce application to once a day or every other day. For products intended to be applied to the skin and left on (i.e. cream, ointment, etc.): Cover the entire affected areas with a thin layer one to three times daily, or as directed by a health care professional. For products intended to be applied and rinsed from the skin: Apply product to entire affected area and rinse off (after x minutes). Use one to three times daily, or as directed by a health care professional. For products containing salicylic acid, sulfur, resorcinol or resorcinol monoacetate: Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions on this label. Acne Therapy - Page 3 of 10

4 For products containing benzoyl peroxide: Avoid unnecessary sun exposure. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and consult a health care professional. Sensitivity Test for a New User: Irritation and allergic reactions have been reported with the use of benzoyl peroxide products. New users should test for sensitivity by applying product sparingly to one or two small affected areas during the first three days. If excessive burning, redness, itching, or swelling (particularly of the eyes, lips or throat) occurs, discontinue use. If symptoms persist or worsen, consult a health care professional. If no discomfort occurs, follow the directions on this label. Duration of use Use as needed. Risk information Caution(s) and Warning(s): Statement(s) to the effect of: For all products: For external use only. If swallowed, call a Poison Control Centre or a health care professional immediately. Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care professional. Avoid contact with eyes; if contact occurs, rinse thoroughly with water. Discontinue use if excessive skin irritation develops or increases. If irritation persists or spreads beyond the site of application, consult a health care professional. For more severe cases, and/or if substantial improvement is not apparent within 6-8 weeks, consult a health care professional. For products containing Sulfur or Sulfur in combination with Resorcinol or Resorcinol Monoacetate: Apply only to areas with acne. Acne Therapy - Page 4 of 10

5 For products containing Benzoyl Peroxide: Avoid contact with lips, mouth, and nostrils; if contact occurs, rinse thoroughly with water. Avoid contact with hair and dyed fabrics, which may be bleached by this product. In case of allergic reactions, discontinue use and consult a health care professional. Contraindication(s) For products containing Sulfur or Sulfur in combination with Resorcinol or Resorcinol Monoacetate: Do not use o on broken skin. o on large areas of the skin. For products containing Benzoyl Peroxide: Do not use if you o have very sensitive skin. o are allergic/sensitive to benzoyl peroxide or any other ingredient in the product. Known Adverse Reaction(s) For all products: This product may cause irritation, burning, itching, swelling and blistering of the skin. If this occurs, discontinue use. If you develop severe itching, hives, swelling of eyes and mouth, blistering or difficulty breathing, consult a health care professional. Acne Therapy - Page 5 of 10

6 PRODUCT FACTS TABLE: RECOMMENDED (NOT MANDATORY) Product Facts Active ingredient (in each dosage unit) Purpose Salicylic acid XX %..... Acne Treatment Uses Treatment or management of acne: Helps treat acne pimples Helps keep skin clear of new acne pimples Dries and helps clear up acne pimples Warnings For external use only. Reduces the number and/or severity of acne pimples Helps prevent new acne pimples from forming Penetrates pores to help control acne pimples Skin Reactions: This product may cause irritation, burning, itching, swelling and blistering of the skin. If any of the above noted symptoms occur, discontinue use. Do not use on broken skin. on large areas of the skin. Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time because this may increase the development of dryness or peeling of the skin. When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if the skin reaction becomes severe or spreads beyond the site of application. you develop severe itching, hives, swelling of eyes and mouth, blistering or difficulty breathing. substantial improvement is not apparent within 6-8 weeks. Keep out of reach of children. If swallowed, call a Poison Control Centre or a health care professional immediately. Directions Cleanse skin thoroughly before applying the product. For New Users: Apply product to a small area once a day for three days to test if you are sensitive to this product. If no discomfort occurs, cover the entire affected area with a thin layer and (optional: after x minutes) rinse off. Start with one application daily, then gradually increase to two or three times daily, if needed. If dryness or peeling occurs, reduce application to once a day or every other day. Other information Inactive ingredients: <List all NMIs> Questions? Concerns? Call XXX-XXXX Acne Therapy - Page 6 of 10

7 PRODUCT FACTS TABLE: RECOMMENDED (NOT MANDATORY) 7 Product Facts Active ingredient (in each dosage unit) Purpose Benzoyl Peroxide XX %.... Acne Treatment Uses Treatment or management of acne: Prevents and kills acne bacteria Helps treat acne pimples Helps keep skin clear of new acne pimples Dries and helps clear up acne pimples Warnings For external use only Reduces the number and/or severity of acne pimples Helps prevent new acne pimples from forming Penetrates pores to help control acne pimples Skin Reactions: This product may cause irritation, burning, itching, swelling and blistering of the skin. If any of the above noted symptoms occur, discontinue use. Do not use if you have very sensitive skin. if you are sensitive or allergic to benzoyl peroxide or to any other ingredient in this product. Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time because this may increase the development of dryness or peeling of the skin. When using this product Avoid unnecessary sun exposure and use a sunscreen. Avoid contact with eyes, lips, nostrils and mouth. If contact occurs, rinse thoroughly with water. Avoid contact with hair and dyed fabrics. Stop use and ask a doctor if the skin reaction becomes severe or spreads beyond the site of application. you develop severe itching, hives, swelling of eyes and mouth, blistering or difficulty breathing. substantial improvement is not apparent within 6-8 weeks. Keep out of reach of children. If swallowed, call a Poison Control Centre or a health care professional immediately. Directions If going outside, apply sunscreen after using this product. Cleanse skin thoroughly before applying the product. For New Users: Apply product to a small area once a day for three days to test if you are sensitive to this product. If no discomfort occurs, cover the entire affected area with a thin layer (For products to be applied and rinsed off: Apply product to the entire affected area and rinse off after x minutes). Start with one application daily, then gradually increase to two or three times daily, if needed. If dryness or peeling occurs, reduce application to once a day or every other day. Other information This product may bleach hair or dyed fabrics. Inactive ingredients <List all NMIs> Questions? Concerns? Call XXX-XXXX 7 The regulatory amendment for a Fact Table for non-prescription drug products would come into force three years after the day of registration in Canada Gazette Part II (June 13, 2017). Acne Therapy - Page 7 of 10

8 Non-medicinal ingredients Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) 8 and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR) 9, the Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use 10 policy, and/or the current Cosmetic Ingredient Hotlist 11, when relevant. Specifications For products containing ingredients listed in Table 1: NHP medicinal ingredients and associated doses: The finished product must be established in accordance with the requirements described in Health Canada s Quality of Natural Health Products Guide, available at dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php. For products containing the ingredient from Table 2: Drug medicinal ingredient: Health Canada s Guidance Document: Labelling of Pharmaceutical Drugs for Human Use should be consulted for applicable labelling requirements. Products must comply with the requirements in the Food and Drugs Act and associated Regulations. It is also noted that all products are subject to Part C, Division 2 of the Food and Drug Regulations. When applicable, the medicinal ingredient(s) should comply with the specifications outlined in the associated monograph from the standards listed on Schedule B to the Food and Drugs Act. Where no Schedule B monograph exists for the finished product s dosage form, specifications should be similar to those of a comparable compendial dosage form, demonstrating the product s identity, potency, purity and quality. Products that contain medicinal ingredients not included in Table 2 may be considered New Drugs as per section C of the Food and Drug Regulations. 8 Health Canada Government of Canada Health Canada Health Canada 2014a Acne Therapy - Page 8 of 10

9 References AHFS 2015: American Hospital Formulary Service. McEvoy GK (ed). AHFS Drug Information [Internet] Published by Authority of the Board of the American Society of Health-System Pharmacists, Bethesda, Maryland. [Accessed 2015 October 07]. Available from: Daniel L. Krinsky, Stefanie P. Ferreri, Brian Hemstreet, Anne L. Hume, Gail D. Newton, Carol J. Rollins, Karen J. Tietze editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 18 th edition. Washington (DC): American Pharmaceutical Association; FDA 2015: USA Department of Health and Human Services: Food and Drug Administration, CFR 333 subpart D Topical Acne Product FDA 2011: USA Department of Health and Human Services: Food and Drug Administration, 2011 Guidance for Industry OTC Acne Product Compliance guide FDA 2010: USA Department of Health and Human Services: Food and Drug Administration, CFR Part 333. Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use, Final Rule. [Accessed ]. O'Neil MJ, Maryadele J. The Merck Index Online: An Encyclopedia of Chemicals, Drugs, and Biologicals. 14 th edition. Whitehouse Station (NJ): Merck and Co., Inc; Sweetman SC, editor. Martindale: The Complete Drug Reference. Online edition. Pharmaceutical Press; 2015 [Accessed ]. USP 38: The United States Pharmacopeia and the National Formulary (USP 38/NF 33). Rockville (MD): United States Pharmacopeial Convention, Inc.; Acne Therapy - Page 9 of 10

10 Appendix 1: Dosage forms that fall outside the scope of this monograph The following dosage forms for acne products are associated with indications of use that fall outside the scope of this monograph: Sponge Shampoo Bar soap These, as well as all other dosage forms not identified as acceptable in the Dosage form(s) section of this document, require assessment outside of the monograph stream. Appendix 2: Applications that fall outside the scope of this monograph Applications for products that recommend a sequential treatment regime or products copackaged with another drug, natural health product or cosmetic product will be reviewed outside the monograph. Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph. Acne Therapy - Page 10 of 10