Label: FUNGAL NAIL REPAIR- acetic acid liquid

  • NDC Code(s): 84445-001-01, 84445-001-02
  • Packager: Shenzhen Furuizhilian keji Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 26, 2024

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  • ACTIVE INGREDIENT

    ACETIC ACID 17%

  • PURPOSE

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out ofreach ofchildren

  • INDICATIONS & USAGE

    For all caused by nail fungus
    nail discoloration
    nail thickening
    nail splitting
    nail crumbling

  • WARNINGS

    Flammable, keep away from fire and flames
    For external use only

  • DOSAGE & ADMINISTRATION

    Apply it in the day and night
    Before using it for the first time, soak thediseased nail with warm water to soften it,use the nail file to polish the nail, make itthin visibly, and scrape off the dirt on thenail (be careful not to hurt the nail bed),then apply the liquid
    After first use, every 2-3 days, use the nailfille to polish the surface of the diseasednail and then continue to use it

  • STORAGE AND HANDLING

    Store at 59-86 °F(15-30°C)

  • INACTIVE INGREDIENT

    Water, Alcohol, Phryma Leptostachya Extract,Salicylic Acid, Sophora Flavescens RootExtract, Garden Balsam (Impatiens Balsamina)Leaf Extract

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUNGAL NAIL REPAIR 
    acetic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84445-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)  
    IMPATIENS BALSAMINA LEAF (UNII: LH9E1X602V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84445-001-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2024
    2NDC:84445-001-0235 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 Drug505G(a)(3)06/26/2024
    Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Furuizhilian keji Co., Ltd.418598613manufacture(84445-001)
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