FUNGIFREE Nail Repair Solution

FUNGIFREE Nail Repair Solution by

Drug Labeling and Warnings

FUNGIFREE Nail Repair Solution by is a Otc medication manufactured, distributed, or labeled by YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FUNGIFREE NAIL REPAIR SOLUTION- tolnaftate ointment 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD

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FUNGIFREE Nail Repair Solution

Drug Facts

Active ingredients Purpose

Tolnaftate 1% ..…………………………………………………………………………….Anti-fungal

Uses

Treatment of fingernail and toenail fungus

For external use only

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

When using this product avoid contact with eyes.

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Warnings

Directions

-Soak your feet in hot water for 5 minutes, then dry your toes.

-Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better.

-Gently turn the end of the pen to dispense treatment liquid onto the brush applicator.

-Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts.

-Use daily for 2-4 weeks, according to the condition of the area that needs repair.

Recommended use: 2-3 times a day.

Other information store at 15-28°C (59.0-82.4°F)

Inactive ingredients Cetyl alcohol, Glycerin, Monoolein, Salicylic acid, Stearyl alcohol, Urea, Acetic acid, mineral oil, etc.

FUNGIFREE NAIL REPAIR SOLUTION 
tolnaftate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83364-008(NDC: 84010-013)
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 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
UREA (UNII: 8W8T17847W)
ACETIC ACID (UNII: Q40Q9N063P)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83364-008-01	1 in 1 BOX	06/25/2024	05/31/2025
1		30 g 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	06/25/2024	05/31/2025

Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)

Revised: 6/2025

Document Id: 3842c88d-b70f-5404-e063-6294a90a0bc7

34390-5

Set id: 1bc0f022-0747-a059-e063-6394a90a7375

Version: 2

Effective Time: 20250623

 

YITONGBADA