Label: POISON IVY WASH- pramoxine hcl lotion

  • NDC Code(s): 63868-877-06
  • Packager: Chain Drug Market Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • ACTIVE INGREDIENT

    Pramoxine HCl 1%

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only.

    When using this product:

    Avoid Contact with eyes.

    Do not leave on skin longer than 3 minutes

    Rinse thoroughly after application

  • WHEN USING

    When using this product avoid contact with the eyes. Do not leave on skin longer than 3 minutes. Rinse thoroughly after application.

  • ASK DOCTOR

    Stop use and ask a doctor if condition worses, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • 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 lather and rub for up to 3 minutes if needed. do not leave on skin for longer than 3 minutes. Thoroughly rinse product form all areas. Apply to affected are not more than 3 to 4 times daily.

  • INACTIVE INGREDIENT

    Water

    ammonium lauryl sulfare

    distearyl phtalic acid amide

    glycol distereate

    cocamide MIPA

    Propylene glycol

    Diazolidyn Urea

    Methylparaben
    Propylparaben

    Glycerin

    Jojoba esters

    disodium edta

    sodium hydroxide

    nonoxynol-9

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • PRINCIPAL DISPLAY PANEL

    wash

  • INGREDIENTS AND APPEARANCE
    POISON IVY WASH 
    pramoxine hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-877
    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
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-877-06177 mL in 1 CONTAINER; Type 0: Not a Combination Product04/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/24/2019
    Labeler - Chain Drug Market Association (011920774)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(63868-877) , pack(63868-877) , analysis(63868-877) , label(63868-877)
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