Gold Mountain Beauty Intensive Repair Serum
Tolnaftate Antifungal
Renu Laboratories, Inc.
Human Otc Drug
NDC 76348-418Gold Mountain Beauty Intensive Repair Serum also known as Tolnaftate Antifungal is a human otc drug labeled by 'Renu Laboratories, Inc.'. National Drug Code (NDC) number for Gold Mountain Beauty Intensive Repair Serum is 76348-418. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Gold Mountain Beauty Intensive Repair Serum drug includes Tolnaftate - 2.8 g/28g . The currest status of Gold Mountain Beauty Intensive Repair Serum drug is Active.
Drug Information:
| Drug NDC: | 76348-418 |
| 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: | Gold Mountain Beauty Intensive Repair Serum |
| 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: | Tolnaftate Antifungal |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Renu Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | TOLNAFTATE - 2.8 g/28g
|
| 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: | 02 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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: | part333C |
| 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: | Renu Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 283693
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 06KB629TKV
|
| 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 |
|---|
| 76348-418-02 | 1 BOTTLE, PLASTIC in 1 BOX (76348-418-02) / 28 g in 1 BOTTLE, PLASTIC (76348-418-01) | 02 Jul, 2018 | 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 antifungal
Product Elements:
Gold mountain beauty intensive repair serum tolnaftate antifungal cetyl acetate 2-hydroxyethyl acrylate polysorbate 60 benzoic acid talc hippophae rhamnoides fruit oil cyclomethicone polysorbate 80 menthyl lactate, (-)- water phenoxyethanol olive oil tolnaftate tolnaftate squalane dehydroacetic acid hippophae rhamnoides seed oil menthol diethylene glycol monoethyl ether propylene glycol glycerin dimethiconol (2000 cst) phenyl trimethicone acetylated lanolin alcohols
Indications and Usage:
Uses effectively relieves cracking, scaling and soreness accompanying fungus (tinea pedis) relieves scaling and cracking cures and prevents foot fungus tinea pedis (athlete's foot)
Warnings:
Warnings for external use only avoid contact with eyes, ears or mouth if irritation occurs, discontinue use and consult a doctor if swallowed, get medical help or consult a poison control center immediately do not use on children under 2 years of age unless directed by a doctor if irritation occurs, discontinue use and consult a doctor
When Using:
Do not use on children under 2 years of age unless directed by a doctor
Dosage and Administration:
Directions apply 1-2 pumps of serum onto each foot 2 times daily, paying special attention to rough areas. for keeping skin smooth, apply 1 pump on each foot once a day supervise children in the use of this product
Stop Use:
If irritation occurs, discontinue use and consult a doctor
Package Label Principal Display Panel:
Gold mountain beauty foot therapy intense hydration intensive repair serum foot-serum_box gmb_footserum_bottle
Further Questions:
For questions or comments, please visit: goldmountainbeauty.com