Label: BLISTEX IVAREST MEDICATED POISON IVY CLEANSING FOAM- menthol soap

  • 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 November 19, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 1.0% (w/w)

  • Purpose

    External analgesic

  • Uses

    • for the temporary relief of pain and itching
    • soothes and cools skin
  • Warnings

    For external use only

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if:

    • condition worsens
    • 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 to affected area, gently rubbing to remove urushiol (toxic plant oil). Rinse under running water.
    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: Ask a doctor
  • Inactive ingredients

    acetamide MEA, cocamidopropyl betaine, disodium EDTA, DMDM hydantoin, glycerin, lactamide MEA, PEG-4, PEG-40 hydrogenated castor oil, phenoxyethanol, purified water, sodium lauroyl sarcosinate, triclosan

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    NDC 10157-9012-2

    IVAREST®
    EXTERNAL ANALGESIC

    MEDICATED
    POISON IVY
    CLEANSING FOAM

    Prevents
    Outbreaks
    if used shortly
    after exposure

    Soothes &
    Comforts Skin
    if symptoms have
    already developed

    For Poison Ivy, Oak & Sumac

    Non-Abrasive
    Cooling Cleanser

    6 FL OZ (177mL)

    Principal Display Panel - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BLISTEX   IVAREST MEDICATED POISON IVY CLEANSING FOAM
    menthol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD)  
    N-LACTOYL ETHANOLAMINE (UNII: 900T44YNC7)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9012-2177 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2008
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9012)
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