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

  • NDC Code(s): 10157-8407-1, 10157-8407-2
  • Packager: Blistex Inc.
  • 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 March 30, 2017

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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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/28/2017
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-8407)