Label: REPLENIX ACNE SOLUTIONS WASH- benzoyl peroxide liquid
- 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 December 17, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
INGREDIENTS AND APPEARANCE
REPLENIX ACNE SOLUTIONS WASH
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51326-112 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 mL Inactive Ingredients Ingredient Name Strength Carboxypolymethylene (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:51326-112-01 200 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 FINAL part333D 11/01/2017 Labeler - Topiderm, Inc. (049121643)