Label: FUNGAL NAIL LIQUID- tolnaftate liquid

  • NDC Code(s): 84033-006-01
  • Packager: Qingdao Kuajie Online Electronic Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 9, 2024

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  • ACTIVE INGREDIENT

    TOLNAFTATE 1%

  • INACTIVE INGREDIENT

    ALCOHOL 9ml

    ANGELICA DAHURICA LEAF 1.8g

    SORBITOL 15g

    SALICYLIC ACID 4.7g

    LAUROCAPRAM 0.3g

    PROPANEDIOL 6g

    CHLORHEXIDINE 0.2g

    POLIGLUSAM 3.4g

    WATER 58.6ml

  • PURPOSE

    Fungal Nail Renewal

  • HOW TO USE

    1. First soak your feet in warm water for 5 minutes. Then dry your toes thoroughly.

    2. Employ a fingernail clipper (not included) and a nail file to meticulously eliminate as much damaged nail area as possible. This key step maximizes the absorption potential of our nail fungus treatment liquid.

    3. Apply a proper dosage of the liquid to the areas requiring repair.

  • WARNINGS

    For external use only, do not eat.

    Avoid eye contact. Keep your skin dry and clean.

    No use on severely ulcerated skin.

    This product is not a substitute for medication.

    Do not use it for children under 2 years old unless with a doctor's advice.

  • STOP USE AND ASK A DOCTOR IF

    You are pregnant or have a plan to get pregnant while using the product.

    You are allergic to this product (such as itching, rash swelling of the lips, eyelids and shortness of breath).

  • WHEN USING THIS PRODUCT

    This product can facilitate the recovery of nails suffering from nail fungus. It can aid in averting recurrent athlete's foot through daily usage.

  • STORAGE

    Keep away from direct sunlight or heat!

    Store at room temperature of 15°-30℃ (59°-86℉)

  • KEEP OUT OF REACH OF CHILDREN

    Do not use it for children under 2 years old unless with a doctor's advice.

  • DOSAGE

    Repeat this process 2-3 times daily until a healthy nail starts regenerating gradually.

    For optimal effects, maintain usage for continuous 6 weeks.

  • PRINCIPAL DISPLAY PANEL

    Fungal Nail NDC

  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84033-006
    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
    ANGELICA DAHURICA LEAF (UNII: ONF5ZKM88G) 1.8 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 58.6 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 100 mL
    LAUROCAPRAM (UNII: 1F3X9DRV9X) 0.3 g  in 100 mL
    POLIGLUSAM (UNII: 82LKS4QV2Y) 3.4 g  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 6 g  in 100 mL
    CHLORHEXIDINE (UNII: R4KO0DY52L) 0.2 g  in 100 mL
    SORBITOL (UNII: 506T60A25R) 15 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) 4.7 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84033-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/09/2024
    Labeler - Qingdao Kuajie Online Electronic Technology Co., Ltd (974662026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao Kuajie Online Electronic Technology Co., Ltd974662026manufacture(84033-006) , label(84033-006)
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