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

  • NDC Code(s): 83767-801-01
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 5, 2024

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  • SPL UNCLASSIFIED SECTION

    SIDINOX TOENAIL FUNGUS TREATMENT Liquid

  • ACTIVE INGREDIENT

    TOLNAFTATE 1%
    UNDECYLENIC ACID 25%

  • PURPOSE

    Anti-fungal

  • INDICATIONS & USAGE

    Antifungal treatment for fingernails, toenails, and surrounding skin.Efective against fungal nails, athlete's fcot, tinea manuum,and ringworm caused by fungi.Addresses nail fungus, discoloralionthickening, splitling, and crumbling.

  • WARNINGS

    Keep away from fire and flames.
    Keep out of reach of children.
    For external use on nails and the immediately adjacent skin only.

  • DO NOT USE

    Do not use ifyou experience any signs of sensitivity or irritation

  • WHEN USING

    While using this product:Not for use in the eyes, mouth, or vaginal area.

  • STOP USE

    Stop use and consult a doctor if:
    If the area of application shows increased irritation
    If there is no improvement within 8 weeks.
    If pregnant or breaslleeding.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    If accidental ingestion occurs, seek medical assistance or contact aPoison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Use once daily, preferably before bedtime.
    Unscrew the bottle cap and use the brush to apply the medicine directlyto the nail.The medication will then penetrate deeply into the nail.
    If the nail area is infected, spray the medication onto the affected area.

  • STORAGE AND HANDLING

    SHAKE WELL BEFORE USE.
    Store at 5'C to 30°0(41'F to 86°F) in a cool
    dry place. Keep tighosedand away from sunlight.

  • INACTIVE INGREDIENT

    ALCOHOL
    DIMETHICONE
    C12-15 ALKYL LACTATE
    ETHYLHEXYLGLYCERIN
    TOCOPHEROL
    EDETATE DISODIUM
    PHENOXYETHANOL
    WATER

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SIDINOX TOENAIL FUNGUS TREATMENT LIQUID 
    tolnaftate, undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-801
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-801-012 in 1 PACKAGE09/06/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/06/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-801)
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