IVY-DRY SUPER (BENZYL ALCOHOL, CAMPHOR, MENTHOL) SPRAY [IVY-DRY, INC.]

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IVY-DRY SUPER (BENZYL ALCOHOL, CAMPHOR, MENTHOL) SPRAY [IVY-DRY, INC.]
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NDC 49546-106-06
Set ID 4792a667-2378-4b3d-968d-9efb1866792f
Category HUMAN OTC DRUG LABEL
Packager Ivy-Dry, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Benzyl Alcohol 10%

    Camphor 0.5%

    Menthol 0.25%


    Purpose

    External Analgesic


  • Uses

    • for the temporary relief of itching associated with insect bites and minor skin irritations
  • WARNINGS

    For external use only.

    Do not use

    • on face or genital areas
    • on areas of blistered or broken skin
    • with a compress after application

    When using this product

    • do not get into eyes
    • if contact occurs, flush eyes with water

    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.

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

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

  • Directions

    • Apply to affected area not more than 3 times daily.
    • Children under 6 years of age: do not use, ask a doctor.
    • Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.
    • Test product on small patch of skin before applying to the entire body.
  • Other information

    Store at room temperature

    You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222


  • Inactive Information

    WATER, ISOPROPANOL, ZINC ACETATE, ISOCETETH-20, ZINC LACTATE

  • Package Labeling


    Ivy-Dry Super

    TEMPORARY RELIEF OF PAIN AND ITCHING
    Associated with Minor Skin Irritations and Insect Bites

    External Analgesic


    Manufactured in the USA for:
    Ivy-Dry, Inc.
    299-B Fairfield Avenue
    Fairfield, NJ 07070

    ©2012 Ivy-Dry, Inc.

    Questions or Comments www.ivydry.com



    Ivy-Dry Super

  • INGREDIENTS AND APPEARANCE
    IVY-DRY SUPER 
    benzyl alcohol, camphor, menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49546-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL100 mg  in 1 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ZINC ACETATE (UNII: FM5526K07A)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49546-106-06177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/21/2012
    Labeler - Ivy-Dry, Inc. (800544590)
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