Label: TOXICODENDRON PUBESCENS LEAF liquid

  • NDC Code(s): 53499-1991-4
  • Packager: Schwabe North America, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 9, 2023

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  • Active Ingredient

    Rhus tox (Poison Ivy) 4X

  • Inactive Ingredient 

    ethyl alcohol

    purified water

  • Dosage & Adminstration

    Directions

    Adults and Children 12 years of age and older: Take 10 drops (0.2 ml) in 2 oz of water every 2 hours as needed.

    Children under 12 years of age:  Consult a physician for use.

    As symptoms improve, decrease to once every 4 hours, then twice daily until symptoms disappear.

    Place mixture of Oral Ivy and water under tongue at least 15 minutes before or half hour after eating, brushing teeth or drinking anything except water.

    Indications & Usage 

    Temporarily relieves symptoms of contact dermatitis associated with posion ivy, oak, and sumac, including: itching, red or burning skin rashes, blisters with oozing or crusting, skin irritation, and swelling.

  • Purpose

    Temporarily relieves symptoms of contact dermatitis associated with posion ivy, oak, and sumac, including: itching, red or burning skin rashes, blisters with oozing or crusting, skin irritation, and swelling.

  • Warnings

    Do not use if hypersensitive to this or any other ingredients in this product.  This product contains poison ivy (Rhus tox) plant materials.

  • Stop Use

    Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days. 

    Discontinue use and consult a physician. These can be signs of a serious condition. 

  • Pregnancy and Breast Feeding

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    LBN21900990.A01 Z Oral Ivy Liq 1 oz.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    TOXICODENDRON PUBESCENS LEAF 
    toxicodendron pubescens leaf liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1991
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 29 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-1991-41 in 1 BOX11/17/202104/30/2024
    129 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/17/202104/30/2024
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-1991)
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