Label: ACNE TREATMENT- benzoyl peroxide gel
- NDC Code(s): 76162-229-10
- Packager: Topco associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 17, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- Do not use if you
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When using this product
- skin irritation and dryness is more likely to occur if you use aother 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 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 posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
- stop use and ask a doctor if
- Keep out of reach of children
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Directions
- 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 daily 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
- inactive ingredients
- Questions
- Disclaimer
- Adverse Reaction
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TopCare® Beauty
ACNE TREATMENT
10% Benzoyl Peroxide
Compare to CLEAN & CLEAR® Persa-Gel® 10*
Maximum strength benzoyl peroxide acne medication available under the product monograph
This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.
Dermatologist Tested
PARABEN & PHTHALATE FREE
Fragrance Free
NET WT 1 OZ (28 g)
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INGREDIENTS AND APPEARANCE
ACNE TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-229 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LAURETH-4 (UNII: 6HQ855798J) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-229-10 1 in 1 PACKAGE 08/23/2022 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/23/2022 Labeler - Topco associates LLC (006935977) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(76162-229) Establishment Name Address ID/FEI Business Operations Fidelitone Order Fulfillment 117825116 pack(76162-229)