Humphreys Maravilla
Witch Hazel
Humphreys Pharmacal, Incorporated
Human Otc Drug
NDC 0219-0204Humphreys Maravilla also known as Witch Hazel is a human otc drug labeled by 'Humphreys Pharmacal, Incorporated'. National Drug Code (NDC) number for Humphreys Maravilla is 0219-0204. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Humphreys Maravilla drug includes Witch Hazel - 1 g/mL . The currest status of Humphreys Maravilla drug is Active.
Drug Information:
| Drug NDC: | 0219-0204 |
| 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: | Humphreys Maravilla |
| 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: | Humphreys Pharmacal, Incorporated |
| 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 - 1 g/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: | 11 Jan, 1955 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 2026 |
| 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: | Humphreys Pharmacal, Incorporated
|
| 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: | 0302190204160
|
| 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 |
|---|
| 0219-0204-16 | 473 mL in 1 BOTTLE, PLASTIC (0219-0204-16) | 11 Jan, 1955 | N/A | No |
| 0219-0204-80 | 237 mL in 1 BOTTLE, PLASTIC (0219-0204-80) | 11 Jan, 1955 | 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:
Propósito/purpose astringente astringent
Product Elements:
Humphreys maravilla witch hazel witch hazel witch hazel
Indications and Usage:
Usos/uses: alivia temporalmente irritaciones de la piel debido a: cortadas menores raspaduras menores picaduras de insectos temporarily relieves minor skin irritations due to: minor cuts minor scrapes insect bites
Warnings:
Advertencias / warnings: para uso externo solamente / for external use only. cuando use este producto evite el contacto con los ojos / when using this product avoid contact with eyes.
Dosage and Administration:
Instrucciones/directions: remueva el sello interno / remove protective inner seal humedezca un algodón o almohadilla y limpie suavemente la piel / moisten cotton ball or cleansing pad and gently wipe skin. aplique las veces que sea necesario / apply as often as necessary
Stop Use:
Si los sÃntomas empeoran o persisten por más de 7 dÃas, suspenda su uso y consulte a su médico / stop use and ask doctor if condition worsens or symptoms persist for more than 7 days.
Package Label Principal Display Panel:
Product packaging the labels shown below represent a sample of that currently in use. additional packaging may also be available. humphreys maravilla lotion 100% all natural witch hazel since 1854 astringente - calmante - refrescante maravilla fb labels
Further Questions:
Distribuido por / dist. by: humphreys pharmacal, inc. east hampton, ct 06424 made in usa www.humphreysusa.com