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
  • 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 December 14, 2021

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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?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Benzoyl Peroxide 5%

    Aqueous Base, Acne Treatment Gel

    NET WT 2.1 OZ (60 g)

    Benzoyl Peroxide Image
  • 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 (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 finalpart333D03/13/2012
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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