Label: POISON IVY AND OAK RELIEF- anacardium occidentale, clematis erecta, croton tiglium, cypripedium pubescens, echinacea purpurea, erechtites hieracifolia, graphites grindelia, histaminum hydrochloricum, mezereum, rhus toxicodendron, urtica urens liquid

  • 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 May 28, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Anacardium occidentale, Clematis erecta, Croton tiglium, Cypripedium pubescens, Echinacea purpurea, Erechtites hieracifolia, Graphites, Grindelia, Histaminum hydrochloricum, Mezereum, Rhus toxicodendron, Urtica urens. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3, potencies.​

  • INDICATIONS & USAGE

    Uses for temporary relief of skin irritations related to poison ivy, poison oak, poison sumac, detergents, cosmetics, or other irritants: minor swelling, itching, burning sensation, rashes, skin eruptions with oozing.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day.
    • Children 2-12: 2 sprays 3 times per day.
    • Children 2 mo-2yr: 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if seal is intact. This product has not been independently tested.

  • PURPOSE

    Uses for temporary relief of skin irritations related to poison ivy, poison oak, poison sumac, detergents, cosmetics, or other irritants:

    • minor swelling
    • itching
    • burning sensation
    • rashes
    • skin eruptions with oozing
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    POISON IVY AND OAK RELIEF 
    anacardium occidentale, clematis erecta, croton tiglium, cypripedium pubescens, echinacea purpurea, erechtites hieracifolia, graphites grindelia, histaminum hydrochloricum, mezereum, rhus toxicodendron, urtica urens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT10 [hp_X]  in 59 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP10 [hp_X]  in 59 mL
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED10 [hp_X]  in 59 mL
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT10 [hp_X]  in 59 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA10 [hp_X]  in 59 mL
    ERECHTITES HIERACIIFOLIUS (UNII: 1L6JHK0ORR) (ERECHTITES HIERACIIFOLIUS - UNII:1L6JHK0ORR) ERECHTITES HIERACIIFOLIUS10 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 59 mL
    GRINDELIA HIRSUTULA WHOLE (UNII: C08B09D8UJ) (GRINDELIA HIRSUTULA WHOLE - UNII:C08B09D8UJ) GRINDELIA HIRSUTULA WHOLE10 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 59 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK10 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0116-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/27/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0116)