TOXICODENDRON PUBESCENS LEAF liquid

TOXICODENDRON PUBESCENS LEAF by

Drug Labeling and Warnings

TOXICODENDRON PUBESCENS LEAF by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 doctor.

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, 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, 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 right away.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TOXICODENDRON PUBESCENS LEAF 
toxicodendron pubescens leaf liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-2991
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	4 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-2991-4	1 in 1 BOX	03/02/2023
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/02/2023

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-2991)