Otc - Active Ingredient
Undecylenic Acid 25%
Eternal Spirit Beauty Fungi Fresh
FDA Label NDC 70947-025
11 label sections · Submitted to the FDA by Worldwide Cosmetics, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Worldwide Cosmetics, Inc for the product Eternal Spirit Beauty Fungi Fresh (NDC 70947-025). 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, otc - purpose, uses:, warnings, extremely flammable, otc - stop use, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Uses:
• Cures most athlete’s foot (tinea pedis) and ringworm
(tinea corporis).
• Relieves itching, scaling, cracking, burning, and redness.
Warnings
.• For external use only.• Do not use on children under 2 years of age unless directed by a doctor.• Avoid contact with eyes. If contact occurs, rinse thoroughly with water
Extremely Flammable
Keep away from fire or flame.
Otc - Stop Use
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Shake well before using. Wash affected area and
dry thoroughly. Apply a thin layer of the product
over the affected area (around the nails and
underneath nail tips) twice daily or as directed by
a doctor. Supervise children in the use of this
product. For athlete’s foot, pay special attention
to spaces between the toes; wear well fitting,
ventilated shoes and change shoes and socks at
least once daily. For athlete’s foot and ringworm,
use daily for 4 weeks. If condition persists longer,
consult a doctor. This product is not effective on
the scalp or nails.
Other Information:
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredient
Isopropyl Alcohol, Aqua, Tocopheryl Acetate, Melaleuca Alternifolia Leaf Oil, DMDM Hydantoin.
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