Label: ACNE TREATMENT SERUM- benzoyl peroxide gel 

  • NDC Code(s): 55878-101-11, 55878-101-12
  • Packager: Halogent, LLC (DBA Exposed Skin Care)
  • 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 02/13

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE (3.5% W/W)

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • INDICATIONS & USAGE

    INDICATIONS FOR THE TREATMENT OF ACNE

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  • WHEN USING

    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.
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  • STOP USE

    Stop use and ask a doctor if irritation becomes severe

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  • DO NOT USE

    DO NOT USE IF YOU

    • HAVE VERY SENSITIVE SKIN
    • ARE SENSITIVE TO BENZOYL PEROXIDE
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to three times daily
    • Best results achieved if applied while skin is still slightly wet from the Exposed Clearing Tonic.
    • 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.
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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, glycerin, propanediol, carbomer, camellia oleifera leaf extract (green tea extract), melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, ethylhexylglycerin, disodium EDTA, sodium hydroxide.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • QUESTIONS

    Questions? 1-866-404-7656

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  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT SERUM 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55878-101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    PROPANEDIOL  
    CARBOMER 940  
    CAMELLIA OLEIFERA LEAF  
    MELALEUCA ALTERNIFOLIA LEAF  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    EDETATE DISODIUM  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55878-101-12 50 mL in 1 TUBE
    2 NDC:55878-101-11 26 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/07/2013
    Labeler - Halogent, LLC (DBA Exposed Skin Care) (790961697)
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