IVY DRY (BENZYL ALCOHOL, CAMPHOR, MENTHOL) CREAM [IVY DRY, INC.]

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IVY DRY (BENZYL ALCOHOL, CAMPHOR, MENTHOL) CREAM [IVY DRY, INC.]
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NDC 49546-201-28
Set ID 5fe81556-5b5f-4765-9136-796e4974aed0
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 0.6%
    Menthol 0.4%

    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

    • 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.

  • 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.
  • 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 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.

  • 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.
  • Product Labeling

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


    Ivy Dry Cream

    Ivy Dry Cream

  • INGREDIENTS AND APPEARANCE
    IVY DRY 
    benzyl alcohol, camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49546-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 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) MENTHOL0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49546-201-281 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/22/2012
    Labeler - Ivy Dry, Inc. (800544590)
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