Label: BLISTEX LIP MEDEX (petrolatum, menthol, unspecified form, camphor- synthetic, and phenol paste

  • NDC Code(s): 10157-8407-1, 10157-8407-2, 10157-8407-3, 10157-8407-4, view more
    10157-8407-5
  • Packager: Blistex Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 1.0% (w/w)External analgesic
    Menthol 1.0% (w/w)External analgesic
    Petrolatum 59.14% (w/w)Lip protectant
    Phenol 0.54% (w/w)External analgesic
  • Uses

    • for the temporary relief of pain and itching associated with minor lip irritation
    • temporarily protects and helps relieve chapped or cracked lips
    • helps protect lips from the drying effects of wind and cold weather
  • 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

    beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

  • PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack

    NDC 10157-8407-1

    Blistex®

    LIP PROTECTANT/
    EXTERNAL ANALGESIC

    LIP MEDEX®

    Relieves Sore Lips &
    Restores Moisture Balance

    Quickly Cools & Comforts

    NET WT. .25 oz (7.08g)

    PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX LIP MEDEX 
    petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59.14 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 g  in 100 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
    SACCHARIN (UNII: FST467XS7D)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-8407-11 in 1 BLISTER PACK03/28/2017
    17.08 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10157-8407-21 in 1 BLISTER PACK03/28/2017
    210.75 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:10157-8407-33 in 1 BLISTER PACK11/29/2022
    37.08 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:10157-8407-47.08 g in 1 JAR; Type 0: Not a Combination Product01/24/2024
    5NDC:10157-8407-510.75 g in 1 JAR; Type 0: Not a Combination Product01/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01703/28/2017
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-8407)
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