Label: BENZOYL PEROXIDE- benzoyl peroxide liquid 

  • Label RSS
  • NDC Code(s): 45802-280-01, 45802-280-34
  • Packager: Perrigo New York Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active ingredient

    Benzoyl peroxide 5%

    Close
  • Purpose

    Acne medication

    Close
  • Use

    for the treatment of acne

    Close
  • 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)

    Close
  • Directions

    shake well
    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.
    wet area to be cleansed
    apply acne wash and gently massage area for 1-2 minutes
    rinse thoroughly and pat dry
    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.
    Close
  • Inactive ingredients

    carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

    Close
  • Questions or comments?

    1-800-719-9260

    Close
  • Package/Label Principal Display Panel

    Benzoyl Peroxide 5%

    Acne Medication Wash

    Benzoyl Peroxide 5% Label Image
    Close
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-280
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    EDETATE DISODIUM  
    GLYCERIN  
    IMIDUREA  
    WATER  
    SODIUM C14-16 OLEFIN SULFONATE  
    SODIUM HYDROXIDE  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-280-01 142 g in 1 BOTTLE
    2 NDC:45802-280-34 227 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/24/2013
    Labeler - Perrigo New York Inc (078846912)
    Close