Label: IVY DRY- benzyl alcohol, camphor, menthol cream

  • 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 March 20, 2013

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Benzyl Alcohol 10%
    Camphor 0.6%
    Menthol 0.4%

    Purpose

    External Analgesic

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  • Uses

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

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  • Warnings

    For external use only.

    Do not use

    • face or genital areas
    • on a reas 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 breastfeeding

    ask a health professional before use.

    Keep out of reach of children.

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

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  • Directions

    • Apply to affected area not more than 3 times daily.
    • Children under 2 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.
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  • Other information

    • Store at room temperature.
    • You may report a serious adverse reaction to Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222.
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  • Inactive Ingredients

    Water, Structure XL, Cutina GMS, Phenoxol T, Cremaphor CO 40, Butylene Glycol, Zinc Acetate, Steareth-2,
    Steareth-20, Steareth 100, Proaqua ISL, Pelemol IPM, Estol 1543, Glydant Plus, Dimethicone, VE Acetate, Allantoin.

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  • DESCRIPTION

    Made in the U.S.A. for:
    IVY-DRY, INC.
    299-B Fairfield Ave.
    Fairfield, NJ 07070
    ©2012 Ivy-Dry, Inc.
    Questions or Comments
    www.ivydry.com


    If you get Poison Ivy,
    you know you’ll want
    to use a product with
    proven effectiveness
    that you can trust.
    Look no further than
    Ivy Dry Products
    known and trusted
    for over 60 years.
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  • Product Labeling

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


    Ivy Dry Cream

    Ivy Dry Cream

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  • INGREDIENTS AND APPEARANCE
    IVY DRY 
    benzyl alcohol, camphor, menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49546-201
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.6 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ZINC ACETATE (UNII: FM5526K07A)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49546-201-28 1 in 1 BOX
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/22/2012
    Labeler - Ivy Dry, Inc. (800544590)
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