Extra Strength Nail Fungus Treatment
85966-001 Extra Strength Nail Fungus Treatment
3abc0892-e52b-a40f-e063-6294a90a0e35
HUMAN OTC DRUG LABEL
Sep 2, 2025
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
DUNS: 847858432
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
UNDECYLENIC ACID, TOLNAFTATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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.
OTC - WHEN USING SECTION
When using this product · avoid contact with the eyes or damaged skin.
INACTIVE INGREDIENT SECTION
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
WARNINGS SECTION
For external use only, Store in a cool place and avoid sunshine and heat.
OTC - STOP USE SECTION
Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.
OTC - ACTIVE INGREDIENT SECTION
UNDECYLENIC ACID 25%
TOLNAFTATE 1%
OTC - PURPOSE SECTION
Antifungal
OTC - DO NOT USE SECTION
Do not use on children under 2 years of age unless directed by a doctor
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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.