Label: TOENAIL FUNGUS TREATMENT EXTRA STRENGTH PEN- tolnaftate, undecylenic acid liquid

  • NDC Code(s): 85038-001-01
  • 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 Extra Strength Pen

  • ACTIVE INGREDIENT

    TOLNAFTATE 1%
    UNDECYLENIC ACID 25%

  • PURPOSE

    Anti-fungal

  • INDICATIONS & USAGE

    For the effective treatment of nail fungus,discoloration,thick-ening,splitting,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

    Avoid contact with eyes. in case of contact, rinse thoroughly
    with water.

  • STOP USE

    lrritation occurs or discomfort persists.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek medical advice
    immediately or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    Wash and dry your nails before use, Remove the capcovering the brush of the pen.
    Twist the end of the pen clockwise to dispense the liquidonto the brush.
    Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.
    Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.

  • STORAGE AND HANDLING

    Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).

  • 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 EXTRA STRENGTH PEN 
    tolnaftate, undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85038-001
    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
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85038-001-013 in 1 PACKAGE12/11/2024
    15 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(85038-001)
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