Toxicodendron Pubescens Leaf Liquid
FDA Label NDC 53499-2991

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Toxicodendron Pubescens Leaf (NDC 53499-2991). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, dosage & adminstration, indications & usage, purpose, warnings, stop use, pregnancy and breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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