Label: BLISTEX MEDICATED (dimethicone, camphor- synthetic, menthol, and phenol ointment

  • NDC Code(s): 10157-9951-1, 10157-9951-2, 10157-9951-3, 10157-9951-4, view more
    10157-9951-5, 10157-9951-6, 10157-9951-7, 10157-9951-8
  • Packager: Blistex Inc.
  • Category: HUMAN OTC DRUG LABEL

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 December 17, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 0.5% (w/w)External analgesic
    Dimethicone 1.1% (w/w)Lip protectant
    Menthol 0.625% (w/w)External analgesic
    Phenol 0.5% (w/w)External analgesic
  • Uses

    • for the temporary relief of pain and itching associated with minor lip irritation or cold sores
    • temporarily protects and helps relieve chapped or cracked lips
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body or bandage

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

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

  • Directions

    • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: Consult a doctor
  • Inactive ingredients

    allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

  • PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

    Penetrating
    Medication
    And Moisture

    Blistex®
    MEDICATED LIP OINTMENT

    PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   MEDICATED
    dimethicone, camphor (synthetic), menthol, and phenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.1 g  in 100 g
    Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)0.5 g  in 100 g
    Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form0.625 g  in 100 g
    Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    allantoin (UNII: 344S277G0Z)  
    ammonia (UNII: 5138Q19F1X)  
    yellow wax (UNII: 2ZA36H0S2V)  
    edetate calcium disodium anhydrous (UNII: 8U5D034955)  
    calcium hydroxide (UNII: PF5DZW74VN)  
    cetyl alcohol (UNII: 936JST6JCN)  
    glycerin (UNII: PDC6A3C0OX)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    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)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9951-16 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
    2NDC:10157-9951-310 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
    3NDC:10157-9951-42.25 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
    4NDC:10157-9951-58 g in 1 TUBE; Type 0: Not a Combination Product12/01/2000
    5NDC:10157-9951-21 in 1 CARTON12/01/2000
    5NDC:10157-9951-66 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:10157-9951-73 in 1 CARTON12/01/2000
    66 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:10157-9951-84 in 1 CARTON12/01/2000
    76 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34812/01/2000
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9951)
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