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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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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)

  • PURPOSE

    Purpose:

    Skin protectant

    External analgesic

    External analgesic

    External analgesic

  • INDICATIONS & USAGE

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

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

    Warnings: For external use only

  • 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
  • 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
  • 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

  • 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

  • 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

  • PRINCIPAL DISPLAY PANEL

    Blistexv24f.jpg

  • INGREDIENTS AND APPEARANCE
    BLISTEX LIP 
    dimethicone, camphor, menthol, phenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.1 g  in 100 g
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.6 g  in 100 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0028-225 in 1 BOX, UNIT-DOSE08/09/1995
    1.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM08/09/1995
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
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