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

Poison Ivy and Oak Relief by

Drug Labeling and Warnings

Poison Ivy and Oak Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.​

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

Inactive Ingredients:

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

WARNINGS

Warnings

• Stop use and ask a doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, ask a healthcare professional before use.

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: 3 sprays 3 times per day.
• Children ages 2-12: 2 sprays 3 times per day.
• Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if seal is intact. Keep carton for complete drug facts and product information.

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.

PRINCIPAL DISPLAY PANEL

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 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)