Label: PRIVATE LABEL POISON 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 June 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Pramoxine HCl 1%

  • Purpose

    External analgesic

  • Uses

    For temporary relief of pain and itching associated with poison ivy, poison oak, and 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 worsen 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. Thoughly rinse product from all areas. Apply to affected are not more than 3 to 4 times daily. Children under 2 years of age. Consult a doctor.

  • Other Information

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

  • Keep out of reach of children

  • Inactive Ingredients

    Water, Ammonium Laurl Sulfate, Distearyl Phtalic Acid Amide, Glyco 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

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

  • 5th & Co. Poison Ivy Wash

    Poison Ivy Label

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL POISON IVY WASH 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0802-0119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0802-0119-96117000 mg in 1 BOTTLE; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/18/2018
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0802-0119) , pack(0802-0119) , label(0802-0119) , analysis(0802-0119)
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