EXTRA STRENGTH NAIL FUNGUS TREATMENT- undecylenic acid, tolnaftate liquid

Extra Strength Nail Fungus Treatment by

Drug Labeling and Warnings

Extra Strength Nail Fungus Treatment by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

UNDECYLENIC ACID 25%
TOLNAFTATE 1%

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.

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor

WHEN USING

When using this product · avoid contact with the eyes or damaged skin.

STOP USE

Stop use and ask a doctor if . irritation occurs or if there is no improvement within 4 weeks.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH NAIL FUNGUS TREATMENT 
undecylenic acid, tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)
BIOTIN (UNII: 6SO6U10H04)
LAVENDER OIL (UNII: ZBP1YXW0H8)
UREA (UNII: 8W8T17847W)
MENTHOL (UNII: L7T10EIP3A)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
SALICYLIC ACID (UNII: O414PZ4LPZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
ALOE BARBADENSIS LEAF POWDER (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2025
2	NDC: 85966-001-02	2 in 1 BOX	07/25/2025
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/25/2025

Labeler - GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD (847858432)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD		847858432	manufacture(85966-001)