Label: REPLENIX ACNE SOLUTION BENZOYL PEROXIDE WASH- benzoyl peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzoyl Peroxide USP, 5%

  • 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, 5%

    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 SOLUTION BENZOYL PEROXIDE WASH 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-111-01200 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 drugM00611/01/2017
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-111)
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