Toxicodendron Pubescens Leaf
Schwabe North America, Inc
Human Otc Drug
NDC 53499-1991Toxicodendron Pubescens Leaf is a human otc drug labeled by 'Schwabe North America, Inc'. National Drug Code (NDC) number for Toxicodendron Pubescens Leaf is 53499-1991. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Toxicodendron Pubescens Leaf drug includes Toxicodendron Pubescens Leaf - 4 [hp_X]/29mL . The currest status of Toxicodendron Pubescens Leaf drug is Active.
Drug Information:
| Drug NDC: | 53499-1991 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Toxicodendron Pubescens Leaf |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Toxicodendron Pubescens Leaf |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Schwabe North America, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TOXICODENDRON PUBESCENS LEAF - 4 [hp_X]/29mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 17 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Schwabe North America, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0308079009901
|
| UPC stands for Universal Product Code. |
| UNII: | 6IO182RP7A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53499-1991-4 | 1 BOTTLE, DROPPER in 1 BOX (53499-1991-4) / 29 mL in 1 BOTTLE, DROPPER | 17 Nov, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose temporarily relieves these symptoms: 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.
Product Elements:
Toxicodendron pubescens leaf toxicodendron pubescens leaf toxicodendron pubescens leaf toxicodendron pubescens leaf alcohol water
Indications and Usage:
Indications & usage temporarily relieves these symptoms: 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:
Warnings do not use if hypersensitive to this or any other ingredients in this product. this product contains poison ivy ( rhus tox ) plant materials.
Dosage and Administration:
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 these symptoms: 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.
Stop Use:
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.
Overdosage:
Overdose in case of overdose, seek medical help or contact a poison control center immediately.
Package Label Principal Display Panel:
Add image transcription here... lbn21900990.a01 z oral ivy liq 1 oz.jpg