Active Ingredient
Tolnaftate 1%
Gold Mountain Beauty Fungal Nail Eliminator
FDA Label NDC 76348-417
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 Fungal Nail Eliminator (NDC 76348-417). 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 active ingredient, purpose, for external use only, keep out of reach of children, other safety information, inactive ingredients, otc - ask doctor, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
For External Use Only
- Do not use on children under 2 years of age unless directed by a doctor
- 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
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Other Safety Information
Other information
Store at room temperature (59 - 86 degrees F)
Inactive Ingredients
C12-15 Alkyl Benzoate, Ethyldiglycol, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Oil, Trimethylpentanediol/Adipic Acid Copolymer
Otc - Ask Doctor
- If irritation occurs, discontinue use and consult a doctor
Otc - Questions
For questions or comments, please visit: goldmountainbeauty.com
Otc - Stop Use
- If irritation occurs, discontinue use and consult a doctor
Indications & Usage
Trim nails and file the surface using an emery board
Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
Allow solution to soak into nail or skin
Application to adjacent nails is recommended to prevent the spread of infection
Keep affected areas clean and dry throughout the day
Supervise children in the use of this product
Warnings
Warnings
For external use only
- Do not use on children under 2 years of age unless directed by a doctor
- 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.
Dosage & Administration
Directions
- Trim nails and file the surface using an emery board
- Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails
- Allow solution to soak into nail or skin
- Application to adjacent nails is recommended to prevent the spread of infection
- Keep affected areas clean and dry throughout the day
- Supervise children in the use of this product
Package Label.Principal Display Panel
Gmb_fungal-nail-box Approved (Gmb Fungal Nail Box Approved)
Beauty
Foot Therapy
Antifungal
Fungal Nail Eliminator
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