Label: BLEMISH - benzoyl peroxide gel

  • NDC Code(s): 63550-193-23
  • Packager: Kamins Dermatologics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 19, 2010

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

  • ACTIVE INGREDIENT

    Active ingredients:

    Benzoyl Peroxide: 5% Close
  • PURPOSE

    Purpose: Acne Treatment
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children’s reach.
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  • INDICATIONS & USAGE

    A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots.  Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry.

    Uses

    ■ Helps treat acne.

    ■ Dries up acne pimples.

    ■ Helps prevent new acne pimples.

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  • WARNINGS

    Warnings

    For external use only.

    Do not use on

    • broken skin.
    • large areas of the body.

    When using this product,

    • Apply to affected areas only
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with eyes/eye area, lips, mouth and nostrils.  If contact occurs, rinse thoroughly with water.
    • This product may bleach hair or dyed fabrics.
    • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  Only one drug should be used unless directed by a doctor.

    Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

    If swallowed, seek medical assistance or contact a Poison Control Center immediately.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the skin thoroughly befor applying.
    • Cover the entire affected area with a thin layer 1 to 3 times daily.
    • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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, use a sunscreen.  Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: water, alcohol denat., acer saccharum (maple isolate), disodium PEG-12 dimethicone sulfosuccinate, carbomer, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid

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  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    BLEMISH GEL 5%

    30mL / 1.7 fl.oz

    DIN 02248217Blemish front panel image

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  • INGREDIENTS AND APPEARANCE
    BLEMISH 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-193
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63550-193-23 30 mL in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 10/19/2010
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    Name Address ID/FEI Business Operations
    Kamins Dermatologics Inc. 254050784 manufacture, pack, label
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