Label: FUNGAL NAIL LIQUID- tolnaftate liquid

  • NDC Code(s): 84023-501-01
  • Packager: Shenzhen Yangan Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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  • SPL UNCLASSIFIED SECTION

    FUNGAL NAIL LIQUID

  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    for relief and treatment of pain,soreness,and inflammation from nail fungus.
    Symptoms:
    discolored nails
    brittle nails
    nail splitting
    distorted nails

  • WARNINGS

    For external use only

  • DO NOT USE

    Stop Use And See A Doctor IfYou become pregnant or areplanning to get pregnant whileusing the product.You are allergic to this product(such as itching, rash swelling ofthe lips, eyelids, and shortness ofbreath).

  • WHEN USING

    When Using
    Stop Use And See A Doctor IfYou become pregnant or areplanning to get pregnant whileusing the product.You are allergic to this product(such as itching, rash swelling ofthe lips, eyelids, and shortness ofbreath).

  • STOP USE

    If skin becomes red and swollen, or if burning, aching and other forms ofirritation occur, cease using and seek medical advice at once.

    If you are allergic to this product. Ifsymptoms persist for over 7 days orworsen, consult your physician.Ifyou are pregnant or breast-feeding You become pregnant or areplanning to

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Do not use on children under 2 yearsof age unless directed by a doctorAvoid contact with eyes, ears or mouthIf irritation occurs, discontinue useand consult a doctorIf swallowed, get medical help orconsult a poison control centerimmediately

  • STORAGE AND HANDLING

    Store in a cool and dry place.

  • INACTIVE INGREDIENT

    Water
    Acetic Acid
    Sophora Flavescens
    Lonicerae Japonicae flos
    Angelicae
    Glycerin
    Allantoin
    Garlic Extract
    Tea Tree Oi

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84023-501
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GARLIC (UNII: V1V998DC17)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84023-501-011 in 1 BOX03/08/2024
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/08/2024
    Labeler - Shenzhen Yangan Technology Co., Ltd. (419283765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Yangan Technology Co., Ltd.419283765manufacture(84023-501)