Otc - Active Ingredient
Active Ingredient
Tolnaftate 1%
Gold Mountain Beauty Intensive Repair Serum
FDA Label NDC 76348-418
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Gold Mountain Beauty Intensive Repair Serum (NDC 76348-418). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
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
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
Otc - When Using
- Do not use on children under 2 years of age unless directed by a doctor
Otc - Stop Use
- If irritation occurs, discontinue use and consult a doctor
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
Other Information
Store at room temperature (59 - 86 degrees F)
Inactive Ingredients
Acetylated Lanolin Alcohol, Benzoic Acid, Cetyl Acetate, Cyclopentasiloane,
Deionized Water, Dimethicone Copolyl, Dimethiconol, Ethoxydiglycol, Glycerin,
Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil,
Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate copolymer, Menthol (and) Menthyl Lactate,
Olea Europaea (Olive) Oil, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 60, Polysorbate 80,
Propylene Glycol, Squalane, Talc.
Otc - Questions
For questions or comments, please visit:
goldmountainbeauty.com
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
* Please review the disclaimer below.
