Label: REPLENIX ACNE- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide, USP 5%

  • Purpose

    Anti-acne

  • Uses

    • Topical acne medication.
  • 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 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, consult a doctor.
    • May bleach fabrics.

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

    • Cleanse the skin thoroughly before applying.
    • Apply a thin layer daily, then gradually increase to two or three times daily.
    • 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, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    REPLENiX®
    ACNE SOLUTIONS

    Acne Gel
    Benzoyl Peroxide USP, 5%
    Net wt. 2 oz. (57 g)

    Topix Pharmaceuticals, Inc.
    N. Amityville, NY 11701

    PRINCIPAL DISPLAY PANEL - 57 g Tube Label
  • INGREDIENTS AND APPEARANCE
    REPLENIX ACNE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-411-5757 g in 1 TUBE; Type 0: Not a Combination Product01/22/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00601/22/1993
    Labeler - Topiderm, Inc (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc049121643MANUFACTURE(51326-411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-411)
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