Label: MAXIMUM STRENGTH ACNE- benzoyl peroxide 10% gel

  • 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 June 25, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                      Purpose
    Benzoyl Peroxide 10%.............................Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Uses for the treatment of acne

  • WARNINGS

    Warnings
    For external use only.
    Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.
    When using this product • skin irritation and dryness is more likely to occur if you use another
    topical acne medication at the same time. If irritation occurs, only use one topical acne medication
    at a time. • rinse right away with water if it gets in eyes • avoid unnecessary sun exposure and use
    a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed
    fabrics, which may be bleached by this product • skin irritation may occur, characterized by
    redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the
    product less frequently or in a lower concentration.
    Stop use and ask a doctor if skin irritation becomes severe.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
    right away

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions • cleanse the skin thoroughly before applying medication • cover the entire
    affected area with a thin layer one to three times a day • because excessive drying of the skin
    may occur, start with one application daily, then gradually increase to two or three times daily
    if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce
    application to once a day or every other day. • if going outside, use a sunscreen. Allow product
    to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of
    both products and consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients Carbomer, Disodium EDTA, Disodium Lauryl Sulfosuccinate,
    Methylparaben, Sodium Hydroxide, Water.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ACNE 
    benzoyl peroxide 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-878
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Disodium Lauryl Sulfosuccinate (UNII: P160Q81342)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Methylparaben (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-878-0128 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/2011
    Labeler - TopCare (006935977)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(36800-878) , label(36800-878)