FUNGIFREE NAIL FUNGUS TREATMENT- ketoconazole, tolnaftate solution

FungiFree Nail Fungus Treatment by

Drug Labeling and Warnings

FungiFree Nail Fungus Treatment 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]

PRINCIPAL DISPLAY PANEL

Active ingredients Purpose

Ketoconazole 1.7%...................................................................................................................Anti-fungal

Tolnaftate 1.0%.........................................................................................................................Anti-fungal

Treatment of fingernail and toenail fungus

Uses

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 6 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 nails in warm water for 5 minutes, then dry them.

-Cut and trim affected nails.

-Dip the brush (attached on cap) into the treatment solution.

-Apply the solution over the affected parts, including the root(s) of the nail(s).

-Use 2 times a day, in the morning and before sleep.

Inactive ingredients Aqua, Sorbitol, Ethanol, Propylene Glycol, Salicylic Acid, Deacetylated Chitin, Angelica Dahurica, Lactic Acid, Chlorhexidine Acetate, Laurocapram

Other information store at 10-35°C (50.0-95.0°F)

INGREDIENTS AND APPEARANCE

FUNGIFREE NAIL FUNGUS TREATMENT 
ketoconazole, tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83364-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1.7 g  in 100 g
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)
ANGELICA DAHURICA VAR. FORMOSANA WHOLE (UNII: 247A107296)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLIGLUSAM (UNII: 82LKS4QV2Y)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83364-005-01	1 in 1 BOX	05/16/2024
1	NDC: 83364-005-02	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
unapproved drug other		05/16/2024

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