Label: BENZOYL PEROXIDE gel

  • NDC Code(s): 45802-216-01, 45802-216-96
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2024

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  • Active ingredient

    Benzoyl peroxide 5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    Do not use

    if you

    •
    have very sensitive skin
    •
    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.
    •
    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

    •
    irritation becomes severe

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    •
    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
    •
    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 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide

  • Questions or comments?

    1-866-634-9120

  • Package/Label Principal Display Panel

    NDC 45802-216-96

    Benzoyl Peroxide 5%

    Aqueous Base, Acne Treatment Gel

    NET WT 2.1 OZ (60 g)

    carton
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-216-011 in 1 CARTON04/06/2012
    190 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:45802-216-961 in 1 CARTON03/13/2012
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/13/2012
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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