Label: TOENAIL FUNGUS TREATMENT LIQUID- tolnaftate, undecylenic acid liquid

  • NDC Code(s): 83767-701-01, 83767-701-02
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 3, 2024

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  • SPL UNCLASSIFIED SECTION

    TOENAIL FUNGUS TREATMENT Liquid

  • ACTIVE INGREDIENT

    TOLNAFTATE 1%
    UNDECYLENIC ACID 25%

  • PURPOSE

    Anti-fungal

  • INDICATIONS & USAGE

    For the effective treatment of nail fungus, discoloration, thickeningsplitting,crumbling and brittleness.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Children under 2 years of age.
    pregnant or if there is any allergic reaction to this produce.

  • WHEN USING

    When using this product Avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if lrritation occurs or discomfort persists.

  • KEEP OUT OF REACH OF CHILDREN

    If product gets into eyes,flush with water for 15 minutes.

    If swallowed,get medical help or contact a Poison Control Centerright away.

  • DOSAGE & ADMINISTRATION

    For initial use, soak the affected nail in warm water to soften it.Gently fle thenail to make it thinner and remove dirt, being cautiousnot to harm the nail bed.
    Apply full layers of nail solution with brush onto affected areas onaround ,and under nails. A light tingle or burn is normal for the frst10 minutes until the product is absorbed into the skin.
    Apply the product twice a day, in the morning and at night.
    Visible results will be seen in as little as 6 weeks, continue regularusage to prevent fungus regrowth.

  • STORAGE AND HANDLING

    heat above 40'C(104°)
    Store between 15° to 30 °C (59°to 86 ℉ )Avoid freezing and excessive

  • INACTIVE INGREDIENT

    ALCOHOL
    DIMETHICONE
    CETOSTEARYL ALCOHOL
    TEA TREE OIL
    PROPYLENE GLYCOL
    TOCOPHEROL
    SAFFLOWER OIL
    WATER

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TOENAIL FUNGUS TREATMENT LIQUID 
    tolnaftate, undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-701-011 in 1 PACKAGE09/03/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83767-701-022 in 1 PACKAGE09/03/2024
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/03/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-701)
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