Label: CLEAR PROOF ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel
- NDC Code(s): 51531-9071-0, 51531-9071-1
- Packager: Mary Kay Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 18, 2020
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- Active ingredient:
For external use only.
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- 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 doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other information
- Inactive ingredients
- Principal Display Panel - 28 g carton
INGREDIENTS AND APPEARANCE
CLEAR PROOF ACNE TREATMENT ACNE MEDICATION
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-9071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Poloxamer 182 (UNII: JX0HIX6OAG) Silicon Dioxide (UNII: ETJ7Z6XBU4) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Sodium Hydroxide (UNII: 55X04QC32I) Docusate Sodium (UNII: F05Q2T2JA0) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Echinacea Purpurea (UNII: QI7G114Y98) Cucumber (UNII: YY7C30VXJT) Horse Chestnut (UNII: 3C18L6RJAZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-9071-1 1 in 1 CARTON 08/16/2016 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51531-9071-0 3 g in 1 TUBE; Type 0: Not a Combination Product 08/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/15/2012 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Kolmar Laboratories Inc. 001535103 manufacture(51531-9071)