Label: ANTIBACTERIAL LOTIONS- cocamidopropyl betaine liquid

  • NDC Code(s): 84260-001-01, 84260-001-02, 84260-001-03
  • Packager: Guangzhou Lvying Biotechnology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 16, 2024

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  • ACTIVE INGREDIENT

    poly (hexamethylenebiguanide) hydrochloride 0.2%

  • PURPOSE

    This product is an antibacterial product forfemale vulva.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN SECTION

  • INDICATIONS & USAGE

    This product is an antibacterial product forfemale vulva.
    Wash your hands before using the productdirectly squeeze the palms of your hands withthis product, and then clean the vulva area.

  • WARNINGS

    For external use only

  • DOSAGE & ADMINISTRATION

    This product is an antibacterial product forfemale vulva.
    Wash your hands before using the productdirectly squeeze the palms of your hands withthis product, and then clean the vulva area.

  • STORAGE AND HANDLING

    Away from direct sunlight and keep in coolplace.

    Keep out of Reach of Children.

    Keep Away form fire or Flame for External Use omly.

  • INACTIVE INGREDIENT

    WATER,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,PORTULACA OLERACEA WHOLE,MENTHA PIPERITA,ALOE VERA LEAF,COCAMIDOPROPYL BETAINE,SOPHORA FLAVESCENS WHOLE

  • PRINCIPAL DISPLAY PANEL

    label1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LOTIONS 
    cocamidopropyl betaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84260-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) (COCAMIDOPROPYL BETAINE - UNII:5OCF3O11KX) COCAMIDOPROPYL BETAINE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84260-001-0170 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2024
    2NDC:84260-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2024
    3NDC:84260-001-03150 mL in 1 BOTTLE; 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(84260-001)
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