Label: ANTI-FUNGAL LIQUID- tolnaftate liquid

  • NDC Code(s): 84033-003-01
  • Packager: Qingdao Kuajie Online Electronic Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • INACTIVE INGREDIENT

    WATER 58.6 mL
    POLIGLUSAM 3.4 g
    CHLORHEXIDINE 0.2 g
    PROPANEDIOL 6 g
    LAUROCAPRAM 0.3 g
    SALICYLIC ACID 4.7 g
    SORBITOL 15 g
    ANGELICA DAHURICA LEAF 1.8 g
    ALCOHOL 10 mL

  • PURPOSE

    Fungal Nail Renewal

  • HOW TO USE

    1.Apply the product twice a day, in themorning and at night.

    2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

    3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

  • WARNINGS

    For extemmal use only, do not ingest.

    Avoid eye contact: maintaln dry and clean skin.

    Exercise caution when using on severely ulcerated skin.

    This product is not a substitute for medication.

    Do not use on children under 2 years of age unless directed by a doctor.

  • STOP USE AND ASK A DOCTOR IF

    You become pregnant or are planning.to get pregnant while using the product.

    You are allergic to this product (such a itching, rash swelling of the lips, eyelidsand shortness of breath).

  • WHEN USING THIS PRODUCT

    Fungal nails, Athlete's Foot, Tinea ManuumJock ltch, Ringworm caused by fungus andbacterial.

    Helps prevent most athlete's foot with daily use.

    For effective relief of itching, burning and cracking.

  • STORAGE

    Store at room temperature

    15°-30℃(59°-86℉).

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from direct sunlight or heat!

  • DOSAGE

    1.Apply the product twice a day, in themorning and at night.

    2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

    3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

  • PRINCIPAL DISPLAY PANEL

    Tolnaftate2

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84033-003
    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
    ALCOHOL (UNII: 3K9958V90M) 10 mL  in 100 mL
    ANGELICA DAHURICA LEAF (UNII: ONF5ZKM88G) 1.8 g  in 100 mL
    SORBITOL (UNII: 506T60A25R) 15 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) 4.7 g  in 100 mL
    LAUROCAPRAM (UNII: 1F3X9DRV9X) 0.3 g  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 6 g  in 100 mL
    CHLORHEXIDINE (UNII: R4KO0DY52L) 0.2 g  in 100 mL
    POLIGLUSAM (UNII: 82LKS4QV2Y) 3.4 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 58.6 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84033-003-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/02/2024
    Labeler - Qingdao Kuajie Online Electronic Technology Co., Ltd (974662026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao Kuajie Online Electronic Technology Co., Ltd974662026label(84033-003) , manufacture(84033-003)