Label: POISON IVY AND POISON OAK RELIEF- croton tiglium seed,toxicodendron pubescens leaf and xerophyllum asphodeloides tablet

  • 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 December 13, 2022

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  • PURPOSE

    Relieves Itching, Burning, Swelling, Blisters, Redness and Skin Irritations

  • Drug Facts

    Active ingredientsPurpose
    Croton Tig 9X HPUSitching, oozing eruptions
    Rhus Tox 6X HPUSred, swollen eruptions with itching, followed by crusting
    Xerophyllum 6X HPUSitching, stinging, burning skin irritations

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

  • Uses

    ■Temporarily relieves the following symptoms after contact with poison ivy or poison oak:
    ■ red, swollen eruptions ■ itchy, stinging or burning skin irritations
    ■ watery blisters sometimes followed by oozing or crusting

  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding.

    Do not use more than directed.

    Consult a physician if symptoms such as irritation, pain or redness persist for more than 7 days or worsen.

    Keep this and all medications out of the reach of children.

    In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults and children
    12 years and over

    Dissolve 2-3 tablets under tongue every 2 hours

    for up to 4 doses, then every 4 hours until relieved.
    Children 6 years to
    under 12 years     		Dissolve 1-2 tablets under tongue every 2 hours
    for up to 4 doses, then every 4 hours until relieved.
    Children under 6 yearsConsult a physician.

  • Other information

    • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions or comments?

    (800) 624-9659

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • Principal Display Panel - 50 Tablets Bottle Carton

    HOMEOPATHIC

    NDC 54973-4003-1

    SINCE 1903

    Hyland's

    POISON IVY &

    POISON OAK

    RELIEF*

    NATURAL ACTIVE INGREDIENTS - GENTLE ON YOU

    Relieves Itching, Burning, Swelling,
    Blisters, Redness and
    Skin Irritations

    50 QUICK-DISSOLVING

    TABLETS

    NATURAL

    RELIEF

    *SEE NOTE ON BACK PANEL BELOW DRUG FACTS

    carton

  • INGREDIENTS AND APPEARANCE
    POISON IVY AND POISON OAK RELIEF 
    croton tiglium seed,toxicodendron pubescens leaf and xerophyllum asphodeloides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED9 [hp_X]
    XEROPHYLLUM ASPHODELOIDES (UNII: 9I4XB1GP2B) (XEROPHYLLUM ASPHODELOIDES - UNII:9I4XB1GP2B) XEROPHYLLUM ASPHODELOIDES6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4003-11 in 1 CARTON11/01/2019
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2019
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-4003) , pack(54973-4003) , label(54973-4003)
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