Oral Ivy (Rhus toxicodendron)

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]

TOXICODENDRON PUBESCENS LEAF- toxicodendron pubescens leaf liquid 
Schwabe North America, Inc

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.

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Oral Ivy (Rhus toxicodendron)

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 physician for use.

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, and 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, and 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 immediately.

Add image transcription here...

TOXICODENDRON PUBESCENS LEAF 
toxicodendron pubescens leaf liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-1991
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 29 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: 53499-1991-4	1 in 1 BOX	11/17/2021	04/30/2024
1		29 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		11/17/2021	04/30/2024

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-1991)

Revised: 3/2023

Document Id: 4269b0c6-eaaf-4034-b9e3-931f7c92edf1

34390-5

Set id: 6c04d7c0-3027-4db3-a5c5-a6147cd08add

Version: 3

Effective Time: 20230309