Label: BENZOYL PEROXIDE 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 August 10, 2016

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

  • Drug Facts

    Active Ingredient Purpose

    Benzoyl Peroxide 10% Acne Treatment

  • Use

    For the treatment of acne

  • Directions

    Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry

    use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other

    day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops,

    discontinue use of both products and consult a doctor

  • Warnings

    For external use only

    Do not use if you have very sensitive skin of if you are sensitive to benzoyl peroxide

    When using this product avoid unnecessary sun exposure and use a sunscreen using other topical acne drugs at the same time or right

    after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a

    doctor. Irritation may develop, such as redness, burning, itching, peeling, or possibly swelling more frequent use or higher concentraions may

    aggravate such irritation: mild irritation may be reduced by using the product less frequently or in lower concnetraion. Keep away from eyes,

    lips, mouth It may bleach hair of dye fabrics

    Stop use and ask a doctor if irritaion becomes severe and continue.

  • Inactive Ingrdients

    Purified water, Carbomer, Cetearth 20 cetearyl alcohol, DMDM Hydantoin, EDTA, Peg 40 Hydrogenated castor oil, Ethyl Glycol Mono Stearate, Mineral Oil, Methyl and Propyl Paraben, Peg 200 dilurate, Glycerin, silicon oil, Stearic acid, stearyl alcohol, TEA, Magnesium aluminium silicate powder

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chlidren. If swallowed, get medical help or contact Poison Control Center right away

  • STORAGE AND HANDLING

    Store at room temperature 15°-30°C (59°-86°F)

  • DOSAGE & ADMINISTRATION

    Use 2 to 3 times daily or as directed by a doctor.

  • PRINCIPAL DISPLAY PANEL

    Label of Tube

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-019
    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)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PEG-200 DILAURATE (UNII: TWV5J70L88)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON (UNII: Z4152N8IUI)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    DIETHYLENE GLYCOL DISTEARATE (UNII: 617Q4OD69O)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-019-0256 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/31/2015
    Labeler - GERITREX LLC (112796248)
    Registrant - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-019)