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

  • NDC Code(s): 85038-002-01, 85038-002-02
  • Packager: Lianjiang Shanlilai E-commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 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,thickening,splitting,crum
    bling and brittleness.

  • WARNINGS

    For externat use only.

  • DO NOT USE

    chlldren 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

    oif product gets Into eyes,flush with water for 15 minutes.

    if swallowred,get medical help or contact a Poison Control Center rightaway.

  • DOSAGE & ADMINISTRATION

    For initlal use, soak the affected part and soften the nalt in warm water.Gently remove dirt from the naiis, being careful not to damage the nail bed.
    Apply full layers of nait solution with brush onto affected areas on ,around.and under nails,.A light tingle or burn is normal for the frst 10 minutes untilthe product is absorbed into the skin.
    Apply the product twice a day, in the morning and at night.
    Visible resuits will be seen in as little as 7 days, carry out regular use toprevent fungal growth.

  • STORAGE AND HANDLING


    Store betwseen 15° to 30 ° C (59° to 86 ° F)Avoid freezing and excessive heat above 40° C(104° F)

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    label2label

  • INGREDIENTS AND APPEARANCE
    TOENAIL FUNGUS TREATMENT LIQUID 
    tolnaftate, undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85038-002
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85038-002-011 in 1 PACKAGE12/11/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:85038-002-022 in 1 PACKAGE12/11/2024
    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 DrugM00512/11/2024
    Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lianjiang Shanlilai E-commerce Co., Ltd.638192827manufacture(85038-002)
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