Label: DRUGGIST FUNGAL NAIL RENEWAL- fungal nail renewal liquid

  • NDC Code(s): 83872-262-01
  • Packager: Shenzhen Xiaomai Manufacturing Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 26, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient


    Toinaftate 1%
    Undecylenic Acid 25%

  • ​Purpose


    -Fungal nails, Athlete's Foot, Tinea Manuum Jock ltch, Ringworm caused by fungus and bacterial infection.

  • Use


    -For all caused by nail fungusnail discoloration,nail thickening,nail splitting,nail crumbling.

  • Warnings


    * For external use only, do not ingest.
    * Avoid eye contact; maintain dry andclean skin.
    * Exercise caution when using on severelyulcerated skin.
    * Keep out of reach of children.
    * This product is not a substitute formedication.

  • Do not use

    * For external use only, do not ingest.

  • When Using

    * Avoid eye contact; maintain dry andclean skin.
    * Exercise caution when using on severelyulcerated skin.

  • Stop Use

    Stop use and ask a doctor if rash occurs

  • Ask Doctor

    Stop use and ask a doctor if rash occurs

  • Keep Oot Of Reach Of Children

    Keep out of reach of children.

  • Directions

    1.Apply the product twice a day, in the morning and at night.
    2. For initial use, soak the affected nail in wam water to soften it. Gently file the nail to make it thinner and remove dirt, being cautious not to harm the nail bed. Apply the product after this step.
    3. After the first application, repeat every 2-3 days. File the surface of the affected nail and continue regular usage.
    *In case of ingestion, seek medical assistance or contact a poison control center immediately.

  • Other information

    Please store in a cool, dry place away from direct sunlight.

  • Inactive ingredients


    Ethyl Lactate, Aqua,Lactic Acid,Resacetophenone,Acetic Acid, Sophora Flavescens Extract,Stellera Chamaejasme Leaf/Stem Extract,Crocus Sativus Style Extract,Eucalyptol,Olive Oil,Lavender,Aloe Barbadensis Leaf Extract, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene,Lavandula Angustifolia (Lavender) Oil,Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil,Prunus Amygdalus Dulcis (Sweet Almond) Oil,Sesamum indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    DRUGGIST FUNGAL NAIL RENEWAL 
    fungal nail renewal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID10 g  in 30 mL
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE3 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL LACTATE (UNII: F3P750VW8I)  
    2-METHYLLACTIC ACID (UNII: DMW250U2HF)  
    (2-NAPHTHYLOXY)ACETIC ACID (UNII: 717GVR334R)  
    RESACETOPHENONE (UNII: UC3V356VZC)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83872-262-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02906/26/2024
    Labeler - Shenzhen Xiaomai Manufacturing Co., Ltd. (712999147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Xiaomai Manufacturing Co., Ltd.712999147manufacture(83872-262)