Label: FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID- tolnaftate liquid

  • NDC Code(s): 83767-501-01
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 28, 2024

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  • SPL UNCLASSIFIED SECTION

    FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid

  • ACTIVE INGREDIENT

    Tolnaftate 1%
    Undecylenic Acid 25%

  • PURPOSE

    Anti-fungal and Nail Renewal

  • INDICATIONS & USAGE

    Antifungal use on fingemails, toenails, and the immediately adjacent skin.
    Prevents the recurence of most athlete's foot with daily use
    For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.

  • WARNINGS

    For external use only.

  • DO NOT USE

    on children under 2 years of age unless directed by a doctor

  • WHEN USING

    avoid contact with the eyes.

  • STOP USE

    Imitation occurs
    There is no improvement within 4 weeks

  • KEEP OUT OF REACH OF CHILDREN

    If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.

  • DOSAGE & ADMINISTRATION

    Apply once daily, preferably at bedtime or at least eight hours beforewashing. Clean and thoroughly dry the affected area, then use theapplicator brush provided to cover all affected nails. Ensure that theapplication is evenly distrnbuted across the entire nail plate

  • STORAGE AND HANDLING

    Store at room temperature 15--30°C(59°-86°F)
    Protect from freezing; if freezingoccurs, wamm to room temperature
    Keep tightly closed when not in use

  • INACTIVE INGREDIENT

    ALCOHOL
    DIMETHICONE
    C12-15 ALKYL LACTATE
    ETHYLHEXYLGLYCERIN
    SOPHORA FLAVESCENS ROOT
    TOCOPHEROL
    PHENOXYETHANOL
    WATER

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-501-012 in 1 PACKAGE08/28/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/28/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-501)
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