Label: REPLENIX ACNE SOLUTION BENZOYL PEROXIDE WASH- benzoyl peroxide liquid
- NDC Code(s): 51326-111-01
- Packager: Topiderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
- When using this product avoid unnecessary sun exposure and use a sunscreen.
- For external use only.
- Keep away from eyes, lips, and mouth.
- If irritation or sensitivity develops, discontinue use and consult a doctor.
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- May bleach fabrics.
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
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INGREDIENTS AND APPEARANCE
REPLENIX ACNE SOLUTION BENZOYL PEROXIDE WASH
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51326-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51326-111-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M006 11/01/2017 Labeler - Topiderm, Inc. (049121643) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(51326-111) Establishment Name Address ID/FEI Business Operations Topix Pharmaceuticals, Inc. 117745066 PACK(51326-111)