Label: BLISTEX COLD AND ALLERGY LIP SOOTHER- dimethicone and pramoxine hydrochloride stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 12, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0%(w/w)Skin protectant
    Pramoxine HCL 1.0%(w/w)External analgesic
  • Uses

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

    For external use only

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for 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 liberally to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Inactive ingredients

    C20-40 pareth-3, camellia sinensis leaf extract, castor oil bis-hydroxypropyl dimethicone esters, chamomilla recutita (matricaria) flower extract, ethyl menthane carboxamide, flavor, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, honey, lanolin, lecithin, microcrystalline wax, myristyl myristate, ozokerite, paraffin, phenoxyethanol, polybutene, purified water, sambucus nigra fruit extract, sodium ascorbyl phosphate, sodium hyaluronate, sodium saccharin, tocopheryl acetate, tridecyl neopentanoate, triethanolamine, triisononanoin

  • PRINCIPAL DISPLAY PANEL 4.25g Carton

    NDC 10157-9860-1

    Blistex®
    New!
    EXTERNAL ANALGESIC/
    LIP PROTECTANT

    COLD &
    ALLERGY
    LIP SOOTHER™

    Relieves Lip Discomfort & Dryness
    Due To Illness Or Medication

    Infused With Vitamins C&E, Green Tea,
    Elderberry, Chamomile And Honey

    Applies Gently To Sore Lips

    NET WT. .15 oz (4.25g)

    Principal Display Panel 4.25g Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   COLD AND ALLERGY LIP SOOTHER
    dimethicone and pramoxine hydrochloride stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9860
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    green tea leaf (UNII: W2ZU1RY8B0)  
    chamomile (UNII: FGL3685T2X)  
    ethyl menthane carboxamide (UNII: 6S7S02945H)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    sunflower oil (UNII: 3W1JG795YI)  
    honey (UNII: Y9H1V576FH)  
    lanolin (UNII: 7EV65EAW6H)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    paraffin (UNII: I9O0E3H2ZE)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    water (UNII: 059QF0KO0R)  
    european elderberry (UNII: BQY1UBX046)  
    sodium ascorbyl phosphate (UNII: 836SJG51DR)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    tridecyl neopentanoate (UNII: 3Z8H1DA7J5)  
    tangerine (UNII: KH3E3096OO)  
    ceresin (UNII: Q1LS2UJO3A)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9860-11 in 1 CARTON
    14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/01/2011
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE
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