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

  • 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 November 13, 2012

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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

    Blistex.jpg

    Blistex.jpg

  • INGREDIENTS AND APPEARANCE
    BLISTEX LIP 
    dimethicone, camphor, menthol, phenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0029
    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:50332-0029-225 in 1 BOX, UNIT-DOSE
    1.5 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/09/1995
    Labeler - HART Health (069560969)