Label: ANTI-BACTERIAL GEL- chlorhexidine diacetate gel

  • NDC Code(s): 84260-002-01, 84260-002-02
  • Packager: Guangzhou Lvying Biotechnology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • ACTIVE INGREDIENT

    chlorhexidine diacetate 0.12%

  • PURPOSE

    Sterilization

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children.

  • INDICATIONS & USAGE

    Clean hands and vulva before use, fear openthe package and remove the sterile capPlace the booster into the gel tube and slowlypush the gel deep into the vagina. Dispose ofthe gel after withdrawal.

  • WARNINGS

    For external use only

  • DOSAGE & ADMINISTRATION

    Clean hands and vulva before use, fear openthe package and remove the sterile capPlace the booster into the gel tube and slowlypush the gel deep into the vagina. Dispose ofthe gel after withdrawal.

  • STORAGE AND HANDLING

    Away from direct sunlight and keep in coolplace.

  • INACTIVE INGREDIENT

    water
    HYDROXYETHYL CELLULOSE
    CNIDIUM MONNIERI
    KOCHIA SCOPARIA
    LEONURUS ARTEMISIA
    SOPHORA FLAVESCENS
    CENTELLA ASIATICA
    DRYOBALANOPS AROMATICA

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL GEL 
    chlorhexidine diacetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84260-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    BASSIA SCOPARIA WHOLE (UNII: 240G38P85Z)  
    CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    LEONURUS JAPONICUS WHOLE (UNII: NIN10Q372V)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    DRYOBALANOPS AROMATICA WHOLE (UNII: 34303GFW6A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84260-002-014 g in 1 TUBE; Type 0: Not a Combination Product04/23/2024
    2NDC:84260-002-023 g in 1 TUBE; Type 0: Not a Combination Product04/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/23/2024
    Labeler - Guangzhou Lvying Biotechnology Co., Ltd (714445262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Lvying Biotechnology Co., Ltd714445262manufacture(84260-002)
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