Label: BPO- 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 May 15, 2018

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

  • Active Ingredient

    Benzoyl Peroxide 8%

  • Purpose

    Acne Medication

  • INDICATIONS & USAGE

    Use treats acne and helps prevent new acne blemishes from forming

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Warning

    For external use only.

    Do not use

    if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

  • When using this product

    • avoid unnecessary sun exposure and use sunscreen
    • keep away from eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
    • 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.
  • Stop use and ask doctor if

    irritation becomes severe.

  • Direction

    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin nay occur, start with one application daily, then gradually increase to two or three times daily
    • if needed or as directed by a doctorif bothersome dryness or peeling ocurs, reduce application to once a day or every other day
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develpos, discontinue use of product and consult a doctor

  • Inactive Ingredients

    aloe barbadebsis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isisirbide, purified water, simethicone and stearyl alcohol.

  • PRINCIPAL DISPLAY PANEL

    Tube

    U Carton

  • INGREDIENTS AND APPEARANCE
    BPO  
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-106-1612 in 1 PACKAGE01/01/205001/01/2050
    11 in 1 CARTON
    142500 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2009
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(42192-106) , label(42192-106) , pack(42192-106)