FDA Label for Extra Strength Nail Fungus Treatment
View Indications, Usage & Precautions
Extra Strength Nail Fungus Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Guangzhou Saweilan Import & Export Trading Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
Otc - Purpose
Antifungal
Indications & Usage
For the effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and brittleness
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
For effective relief of itching, scaling, burning, redness, soreness, and irritation.
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.
Warnings
For external use only, Store in a cool place and avoid sunshine and heat.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product ยท avoid contact with the eyes or damaged skin.
Otc - Stop Use
Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
1. Regularly trim the affected nails and gently file the surface (once a month or as needed).
2. Shake well before use. Wash the affected nails and surrounding skin with soap and water and dry thoroughly.
3. Using a sterile disposable cotton swab or dropper, apply a thin layer of the product over affectedarea twice daily (morning and night). Use a new swab each time to avoid cross-contamination.
4. Allow the product to air-dry completely before putting on socks or shoes to ensure full absorption.
5. For best results, apply daily until a healthy new nail has fully grown out. This product is noteffective on the scalp or nails.
Inactive Ingredient
UREA
ETHOXYDIGLYCOL
PROPYLENE GLYCOL
ALCOHOL DENAT.
TEA TREE OIL
OREGANO OIL
LAVENDER OIL
MENTHOL
ALOE BARBADENSIS LEAF EXTRACT
SALICYLIC ACID
BIOTIN/VITAMIN H
TOCOPHEROL ACETATE / VITAMIN E
AQUA
GLYCERIN
Package Label.Principal Display Panel
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