Label: BLISTEX FOILLE MEDICATED FIRST AID- benzocaine and chloroxylenol ointment

  • NDC Code(s): 10157-9302-3, 10157-9302-4
  • 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 December 14, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Benzocaine 5.0 % (w/w)External analgesic
    Chloroxylenol 0.1 % (w/w)Antiseptic
  • Uses

    • For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
    • First aid to help prevent infection in minor cuts, scrapes and burns.
  • Warnings

    For external use only

    When using this product

    • Avoid contact with the 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.

    • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area.
    • 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 physician.
  • Other information

    • Avoid contact with clothing. Foille may stain certain fabrics.
  • Inactive ingredients

    beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, citric acid, eugenol, hydrogenated coconut oil, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 10157-9302-4

    Foille®
    EXTERNAL ANALGESIC / ANTISEPTIC

    MEDICATED
    FIRST AID OINTMENT

    Fast, Soothing Relief Of Pain Due To:
    Minor Cuts, Scrapes & Burns
    Sunburn • Insect Bites

    Net Wt.
    1 oz. (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   FOILLE MEDICATED FIRST AID
    benzocaine and chloroxylenol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine5 g  in 100 g
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    corn oil (UNII: 8470G57WFM)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    yellow wax (UNII: 2ZA36H0S2V)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    water (UNII: 059QF0KO0R)  
    benzyl alcohol (UNII: LKG8494WBH)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    ceresin (UNII: Q1LS2UJO3A)  
    sodium borate (UNII: 91MBZ8H3QO)  
    calcium hydroxide (UNII: PF5DZW74VN)  
    edetate calcium disodium anhydrous (UNII: 8U5D034955)  
    eugenol (UNII: 3T8H1794QW)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9302-41 in 1 CARTON03/05/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10157-9302-31 in 1 CARTON09/23/2016
    214 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 FINALpart34803/05/2013
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9302)
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