Witch Hazel
Top Care (topco Associates Llc)
Human Otc Drug
NDC 36800-039Witch Hazel is a human otc drug labeled by 'Top Care (topco Associates Llc)'. National Drug Code (NDC) number for Witch Hazel is 36800-039. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Witch Hazel drug includes Witch Hazel - 842 mg/mL . The currest status of Witch Hazel drug is Active.
Drug Information:
| Drug NDC: | 36800-039 |
| 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: | Witch Hazel |
| 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: | Witch Hazel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Top Care (topco Associates Llc) |
| 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: | WITCH HAZEL - 842 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 31 Oct, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 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. |
| Application Number: | part347 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | TOP CARE (Topco Associates LLC)
|
| 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: | 0036800227125
|
| UPC stands for Universal Product Code. |
| UNII: | 101I4J0U34
|
| 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 |
|---|
| 36800-039-16 | 473 mL in 1 BOTTLE, PLASTIC (36800-039-16) | 31 Oct, 2014 | 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 astringent
Product Elements:
Witch hazel witch hazel witch hazel witch hazel alcohol
Indications and Usage:
Uses for relief of minor skin irritations due to: insect bites minor cuts minor scrapes
Warnings:
Warnings for external use only avoid swallowing when using this product avoid contact with the eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away..
When Using:
When using this product avoid contact with the eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions apply to the affected area as often as necessary.
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.
Package Label Principal Display Panel:
Principal display panel witch hazel astringent 14% alcohol by volume for relief of minor skin irritations due to: insect bites minor cuts minor scrapes fl oz (ml) tamper evident: do not use if printed safety seal under cap is broken or missing. distributed by topco associates llc elk grove village, il 60007 topcare@topco.com
Package label topcare health witch hazel witch hazel, usp 86%
Further Questions:
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