Label: FUNGIFREE NAIL FUNGUS TREATMENT- ketoconazole, tolnaftate solution
- NDC Code(s): 83364-005-01, 83364-005-02
- Packager: YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 14, 2024
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PRINCIPAL DISPLAY PANEL
Active ingredients Purpose
Ketoconazole 1.7%...................................................................................................................Anti-fungal
Tolnaftate 1.0%.........................................................................................................................Anti-fungal
Uses
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.
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INGREDIENTS AND APPEARANCE
FUNGIFREE NAIL FUNGUS TREATMENT
ketoconazole, tolnaftate solutionProduct 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)