Label: FUNGAL NAIL TREATMENT liquid

  • NDC Code(s): 84291-002-01
  • Packager: Shenzhen Yuetai Electronic Commerce Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 14, 2024

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  • Active Ingredient(s)

    SALICYLIC ACID 2%

    Chlorhexidine di(acetate) 2%

  • Purpose

    Antifungal

  • Use

    Effectively treats nail fungus, discolouration, spliting,
    thickening, crumbling and brittleness.

  • Warnings

    For external use only, do not ingest.

  • Do not use

    Do not use on pregnant women or children under 2 years of age unless otherwise advised by a doctor.

  • WHEN USING

    Avoid contact with eyes when using this product,if contact occurs rinse thoroughly with water.

    If irritation occurs, discontinue use and consult a physician.If swallowed, call a poison control

    centre or seek medical attention immediately. Exercise caution when using on severely ulcerated

    skin.

  • STOP USE

    Stop and aska doctor if discomfort persists.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children.If swallowed, get medical help or contact PoisonControl Center right away.

  • Directions

    1.Before use, clean the affected area with soap and soak the nail in warm water to soften it.
    2.For toenail fungus, scrape the dirt off the nail and g ently file the thickened part of the fungal nail until
    it's flat (be careful not to damage the nail bed).
    3.You can use a nail file every 2-3 days to polish the surface of the affected area by applying a thin layer
    of liquid to the affected area, the skin under the nail and around the cuticle.
    4.Use twice daily, morning and evening.
    5.Repeat this process 2-3 times a day until a healthy nail begins its gradual degeneration. For best results,
    continue use for a continuous period of 6 weeks.

  • Other information

    Store in a cool, shaded place away from direct
    sunlight. Store at room temperature between
    15-30°C (59-86°F).

  • Inactive ingredients

    Water,Sorbitol,Alcohol,Propylene Glycol,Angelica
    Dahurica,L aurocapram,Caramel,Dimethylol Urea,
    Sunset Yellow

  • Package Label - Principal Display Panel

    12

  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL TREATMENT 
    fungal nail treatment liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84291-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANGELICA DAHURICA LEAF (UNII: ONF5ZKM88G)  
    LAUROCAPRAM (UNII: 1F3X9DRV9X)  
    OXYMETHUREA (UNII: N68H97CAWG)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84291-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/14/2024
    Labeler - Shenzhen Yuetai Electronic Commerce Co., Ltd (403120360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Yuetai Electronic Commerce Co., Ltd403120360manufacture(84291-002)
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