Face Saver Gel
Antiperspirant
Tripak Pharmaceuticals
Human Otc Drug
NDC 82309-024Face Saver Gel also known as Antiperspirant is a human otc drug labeled by 'Tripak Pharmaceuticals'. National Drug Code (NDC) number for Face Saver Gel is 82309-024. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Face Saver Gel drug includes Aluminum Zirconium Tetrachlorohydrex Gly - 16 g/100g . The currest status of Face Saver Gel drug is Active.
Drug Information:
| Drug NDC: | 82309-024 |
| 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: | Face Saver Gel |
| 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: | Antiperspirant |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tripak Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - 16 g/100g
|
| 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: | 01 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | part350 |
| 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: | Tripak Pharmaceuticals
|
| 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: | 0705102201330
|
| UPC stands for Universal Product Code. |
| UNII: | 8O386558JE
|
| 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 |
|---|
| 82309-024-04 | 50 TUBE in 1 CARTON (82309-024-04) / 50 g in 1 TUBE | 01 Feb, 2022 | 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:
Uses: decreases perspiration reduces wetness
Product Elements:
Face saver gel antiperspirant peg/ppg-18/18 dimethicone water aluminum zirconium tetrachlorohydrex gly aluminum zirconium tetrachlorohydrex gly propylene glycol cyclomethicone 5 cyclomethicone 4
Indications and Usage:
Do not use: -on broken skin - on an area that is infected or reddened when using this product ⢠do not use in or near eyes â¢apply to facial area only stop use and ask a doctor if ⢠rash, irritation or sensitivity develops ask a doctor before use if you have kidney disease
Warnings:
For external use only
Dosage and Administration:
Directions ⢠shake well before use ⢠apply a dab to the palms of the hands, apply sparingly â¢apply to the face â¢product can be applied daily for daily use place a dab on hand and apply
Package Label Principal Display Panel:
Ndc# 82309-024-04 label 50 g aluminium zirconium tetrachlorhydrex gly 16% antiperspirant uses: decreases perspiration reduces wetness for external use only do not use: -on broken skin - on an area that is infected or reddened when using this product ⢠do not use in or near eyes â¢apply to facial area only stop use and ask a doctor if ⢠rash, irritation or sensitivity develops ask a doctor before use if you have kidney disease keep out of reach of children if swallowed, get medical help or contact a poison control center right away directions ⢠shake well before use ⢠apply a dab to the palms of the hands, apply sparingly â¢apply to the face â¢product can be applied daily for daily use place a dab on hand and apply other information ⢠store at below 30 °c(86°f) inactive ingredients water, propylene glycol, cydopentasiloxane, cyclotetrasiloxane, peg/ppg-18/18 dimethicone, fragrance