Label: IVY WASH- pramoxine hydrochloride lotion

  • 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 December 14, 2017

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  • Drug Facts

  • active ingredient

    Pramoxine HCl 1%

  • Purpose

    External analgesic

  • Uses

    For temporary relief of pain and itching associated with poison ivy, poison oak, poison summac

  • Warnings

    For external use only

  • When using this product

    Avoid contact with the eyes. Do not leave on skin longer than three minutes. rinse throughly after application.

  • Stop use and ask a doctor if

    conditions worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Directions

    Adult and children 2 years of age and older. Wet affected areas. Apply the product to affected skin and surrounding area. work foam into a lather and rub for up to 3 minutes, if needed. Do not leave on skin for longer than 3 minutes. throughly rinse product from all areas. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age. Consult a doictor.

  • Other Information

    For best results, use near a shower or sink where it is easy to throughly rinse off product.

  • Keep out of reach of children

  • Inactive Ingredients

    Water, Ammonium Laurl Sulfate, Distearyl Phtalic Acid Amide, Glycol Distearate, Cocamide MIPA, Propylene Glycol, (and) Diazodinyl Urea (and) Methylparaben (and) Propylparaben, Glycerin, Jojoba Esters, Disodium EDTA, Sodium Hydroxide, Nonoxynol-9.

  • Questions or Comments?

    1-800-662-3435

  • SPL UNCLASSIFIED SECTION

    Removes urishiol from the skin. For best results, use as soon as possible after contact with poisson ivy is suspected.

  • Principal display panel

    Dual Action with Jojoba. NDC 0395-0119-96. IVY WASH. POISON IVY CLEANER. FAST ACTING ITCH RELIEF. SAFE FOR USE IN CHILDREN. SAFE FOR USE DURING PREGNACY. UNIQUE 2-IN-1 FORMULA. #1) Starts to work in seconds to remove Poison Ivy Oil (Urishiol), and helps minimize the damaging effects of Poison Ivy contamination. #2) Stops itching FAST. 6OZ (177 mL).

    image description

  • INGREDIENTS AND APPEARANCE
    IVY WASH 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0119-96117 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884label(0395-0119) , manufacture(0395-0119) , pack(0395-0119) , analysis(0395-0119)
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