Label: FUNGIFREE NAIL REPAIR SOLUTION- tolnaftate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • PRINCIPAL DISPLAY PANEL

    Drug Facts 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.

  • INGREDIENTS AND APPEARANCE
    FUNGIFREE NAIL REPAIR SOLUTION 
    tolnaftate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-008(NDC:84010-013)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    UREA (UNII: 8W8T17847W)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83364-008-011 in 1 BOX06/25/2024
    130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/25/2024
    Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)
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