Label: BLISTEX LIP- dimethicone, camphor oil, menthol and phenol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Dimethicone 1.1% (w/w)

    Camphor 0.5% (w/w)

    Menthol 0.6% (w/w)

    Phenol 0.5% (w/w)

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  • PURPOSE

    Purpose:

    Skin protectant

    External analgesic

    External analgesic

    External analgesic

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  • INDICATIONS & USAGE

    Uses: for the temporary protection and relief of pain and itching associated with

    • minor lip irritation
    • chapped or cracked lips
    • cold sores
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  • WARNINGS

    Warnings: For external use only

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  • DO NOT USE

    Do not use

    • in the eyes or over large portions of the body
    • on deep or puncture wounds
    • on animal bites
    • on serious burns
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • condition lasts for more than 7 days
    • symptoms clear up and occur again within a few days
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily

    Children under 2 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol

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  • PRINCIPAL DISPLAY PANEL

    Blistex.jpg

    Blistex.jpg

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  • INGREDIENTS AND APPEARANCE
    BLISTEX LIP 
    dimethicone, camphor, menthol, phenol ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0029
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 1.1 g  in 100 g
    CAMPHOR OIL (CAMPHOR OIL) CAMPHOR OIL .5 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL .6 g  in 100 g
    PHENOL (PHENOL) PHENOL .5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    EDETATE CALCIUM DISODIUM  
    CALCIUM HYDROXIDE  
    CETYL ALCOHOL  
    GLYCERIN  
    LANOLIN  
    LAURIC ACID  
    MINERAL OIL  
    MYRISTIC ACID  
    OLEIC ACID  
    PALMITIC ACID  
    PARAFFIN  
    PETROLATUM  
    POLYGLYCERYL-3 DIISOSTEARATE  
    POTASSIUM HYDROXIDE  
    WATER  
    SODIUM HYDROXIDE  
    STEARYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0029-2 25 in 1 BOX, UNIT-DOSE
    1 .5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/09/1995
    Labeler - HART Health (069560969)
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