Label: TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LIQUID- tolnaftate liquid

  • NDC Code(s): 84614-002-01
  • Packager: Shenzhen Ctrip Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid

  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Anti-fungal and Nail Renewal

  • INDICATIONS & USAGE

    Antifungal use on fingemails, toenails, and the immediately adjacent skin.
    Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection.
    For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling

  • WARNINGS

    Keep away from fire and flame.
    Keep out of reach of children.
    For use on nails and the immediately adjacent skin only.

  • DO NOT USE

    If a reaction suggesting sensitivity or iritation occurs.

  • WHEN USING

    Not for ophthalmic, oral, or intravaginal use

  • STOP USE

    lf the area of application shows signs of increased iritation.
    There is no improvement within 8 weeks.
    When Pregnant or breast-feeding

  • KEEP OUT OF REACH OF CHILDREN

    If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.

  • STORAGE AND HANDLING

    SHAKE WELL BEFORE USE
    Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight.
    Keep tightly closed when not in use

  • INACTIVE INGREDIENT

    UNDECYLENIC ACID
    ALCOHOL
    DIMETHICONE
    C12-15 ALKYL LACTATE
    ETHYLHEXYLGLYCERIN
    TOCOPHEROL
    EDETATE DISODIUM
    PHENOXYETHANOL
    WATER

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84614-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84614-002-012 in 1 PACKAGE08/23/2024
    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 DrugM00508/23/2024
    Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Ctrip Technology Co., Ltd.403113060manufacture(84614-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!