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
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-5116-2 - Packager: King Bio 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 24, 2016
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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, LM1 potencies.
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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.
† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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PURPOSE
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients Purpose †
Equal volumes of each ingredient in 10X, 30X, LM1 potencies.
Anacardium occidentale...............................intense itching, swelling
Clematis erecta...........................................red, burning, scaly skin
Croton tiglium........................................severe itching and stinging
Cypripedium pubescens............................................intense itching
Echinacea purpurea..................................................skin irritations
Erechtites hieracifolia............................................red, swollen skin
Graphites.............................................................oozing eruptions
Grindelia................................................severe burning and itching
Histaminum hydrochloricum..................................red, itchy papules
Mezereum.................................................eruption with oozing pus
Rhus toxicodendron........................................intense itching of skin
Urtica urens....................................skin eruptions with burning heat
HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.
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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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5116 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT 10 [hp_X] in 59 mL CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP 10 [hp_X] in 59 mL CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED 10 [hp_X] in 59 mL CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT 10 [hp_X] in 59 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 10 [hp_X] in 59 mL ERECHTITES HIERACIIFOLIUS (UNII: 1L6JHK0ORR) (ERECHTITES HIERACIIFOLIUS - UNII:1L6JHK0ORR) ERECHTITES HIERACIIFOLIUS 10 [hp_X] in 59 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 10 [hp_X] in 59 mL GRINDELIA HIRSUTULA WHOLE (UNII: C08B09D8UJ) (GRINDELIA HIRSUTULA WHOLE - UNII:C08B09D8UJ) GRINDELIA HIRSUTULA WHOLE 10 [hp_X] in 59 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 59 mL DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-5116-2 1 in 1 CARTON 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/27/2014 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-5116)
