NDC 53499-2991 Toxicodendron Pubescens Leaf
Liquid Oral

Product Information

What is NDC 53499-2991?

The NDC code 53499-2991 is assigned by the FDA to the product Toxicodendron Pubescens Leaf which is a human over the counter drug product labeled by Schwabe North America, Inc. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 53499-2991-4 1 bottle, dropper in 1 box / 30 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code53499-2991
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Toxicodendron Pubescens Leaf
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Toxicodendron Pubescens Leaf
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Toxicodendron Pubescens Leaf
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Schwabe North America, Inc
Labeler Code53499
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-02-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Toxicodendron Pubescens Leaf?


Product Packages

NDC Code 53499-2991-4

Package Description: 1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER

Product Details

What are Toxicodendron Pubescens Leaf Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Toxicodendron Pubescens Leaf Active Ingredients UNII Codes

  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A)
  • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (Active Moiety)

Toxicodendron Pubescens Leaf Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Toxicodendron Pubescens Leaf Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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.


* Please review the disclaimer below.