Label: LEADER POISON IVY WASH- pramoxine hydrochloride lotion 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 March 16, 2022

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  • WARNINGS

    When using this product:

    • avoid contact with eyes
    • do not leave on skin longer than 3 minutes
    • rinse thoroughly after application
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water

    Ammonium Lauryl Sulfate

    Distearyl Phthalic Acid Amide

    Glycol Distearate

    Cocamide MIPA

    Propylene Glycol

    Diazolidinyl Urea

    Methylparaben

    Propylparaben Glycerin

    Jojoba Esters

    Disodium EDTA

    Sodium Hydroxide

    Nonxynol-9

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older:

    • Wet the affected area
    • Apply product to affected skin and surrounding area
    • work foam into a lather and rub for up to 3 minutes, if needed
  • INDICATIONS & USAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, week professional assistance or contact a poison control center immediately. (1-800-222-1222)

  • PURPOSE

    External Analgesic

  • ACTIVE INGREDIENT

    Pramoxine HCl 1%

  • PRINCIPAL DISPLAY PANEL

    ivywash

  • INGREDIENTS AND APPEARANCE
    LEADER POISON IVY WASH 
    pramoxine hydrochloride lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0398
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0398-1177 mL in 1 CONTAINER; Type 0: Not a Combination Product02/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
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