IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]

IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]
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NDC 10157-9077-1
Set ID 6f68cbbb-6269-4bb3-8cc9-50b146703b42
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc
Generic Name
Product Class
Product Number
Application Number PART347
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Calamine 14.0 % (w/w)Skin protectant
    Benzyl Alcohol 10.5 % (w/w)External analgesic
    Diphenhydramine Hydrochloride 2.0 % (w/w)External analgesic
  • Uses

    • for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations.
    • dries the oozing and weeping of poison:
      • ivy
      • oak
      • sumac
  • Warnings

    For external use only

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • do not get into eyes.

    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

    • do not use more often than directed
    • as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry.
    • apply Ivarest liberally to form a layer you can not see through.
    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Other information

    Avoid contact with clothing. Ivarest may stain certain fabrics.

  • Inactive ingredients

    bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, PEG-4, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6

  • PRINCIPAL DISPLAY PANEL - 56g Tube Carton

    2 Itch Relievers

    NDC 10157-9077-1

    MAXIMUM STRENGTH
    IVAREST®

    EXTERNAL ANALGESIC/
    POISON IVY, OAK, SUMAC DRYING CREAM

    POISON IVY
    ITCH RELIEF

    8 Hour
    Relief

    MEDICATED ANTI-ITCH CREAM

    Double
    Relief
    Formula

    1
    Antihistamine
    helps stop the reaction
    2
    Analgesic
    soothes itch fast

    PLUS Skin protectant to help dry the rash

    Poison Ivy, Oak & Sumac,
    Insect Bites, Minor Skin Irritations

    NET WT 2 OZ(56g)

    Principal Display Panel - 56g Tube Carton
  • INGREDIENTS AND APPEARANCE
    IVAREST 
    zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide14 g  in 100 g
    Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol10.5 g  in 100 g
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    bentonite (UNII: A3N5ZCN45C)  
    benzethonium chloride (UNII: PH41D05744)  
    lanolin alcohols (UNII: 884C3FA9HE)  
    lanolin oil (UNII: OVV5IIJ58F)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    petrolatum (UNII: 4T6H12BN9U)  
    polyethylene glycol 200 (UNII: R95B8J264J)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    squalane (UNII: GW89575KF9)  
    FD&C yellow no. 5 (UNII: I753WB2F1M)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    camphor (synthetic) (UNII: 5TJD82A1ET)  
    povidone-iodine (UNII: 85H0HZU99M)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9077-11 in 1 CARTON12/31/2007
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/31/2007
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9077)

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