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

    Drug Fact Label

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1.7 g  in 100 g
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83364-005-011 in 1 BOX05/16/2024
    1NDC:83364-005-0230 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/16/2024
    Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)
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