Label: LEADER POISON IVY WASH- pramoxine hydrochloride lotion lotion

  • NDC Code(s): 70000-0398-1
  • Packager: Cardinal Health, 110 dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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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 DrugM01702/15/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
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