KAISER PERMANENTE BENZOYL PEROXIDE (BENZOYL PEROXIDE) GEL [KAISER FOUNDATION HOSPITALS]

KAISER PERMANENTE BENZOYL PEROXIDE (BENZOYL PEROXIDE) GEL [KAISER FOUNDATION HOSPITALS]
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NDC 0179-8703-60
Set ID 16cecac7-0ad4-4269-a6b9-8ab45f0cefdb
Category HUMAN OTC DRUG LABEL
Packager Kaiser Foundation Hospitals
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne treatment

  • Uses

    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 10%

    Maximum strength

    Aqueous base, acne treatment gel

    NET WT 2 OZ (56.7 g)

    Benzoyl Peroxide 10% Image 1
    Benzoyl Peroxide 10% Image 2
  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8703
    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
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0179-8703-601 in 1 CARTON06/08/200706/30/2020
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/08/200706/30/2020
    Labeler - Kaiser Foundation Hospitals (053052619)