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.

Drug Label Information

Updated December 17, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzoyl Peroxide USP, 10%

  • Purpose

    Acne treatment

  • Uses

    BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

  • 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.

    • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
  • Directions

    • Shake well. Wet affected area, wash, and rinse well.
    • Use once or twice daily or as directed by a physician.
    • If bothersome drying or peeling occurs, reduce applications.
    • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
  • Inactive ingredients

    Carbomer, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

  • PRINCIPAL DISPLAY PANEL - 200 ml Tube Label

    REPLENiX®
    ACNE SOLUTIONS

    Acne Wash

    Benzoyl Peroxide USP, 10%

    Net 6.7 fl. oz. (200 ml)

    Topix Pharmaceuticals, Inc.
    N. Amityville, NY 11701

    PRINCIPAL DISPLAY PANEL - 200 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    REPLENIX ACNE SOLUTIONS WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-112-01200 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/01/2017
    Labeler - Topiderm, Inc. (049121643)