Label: LACTO BELLA Y (lactobacillus ferment, sophora flavescens root extract, lavandula angustifolia- lavender oil, sodium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 27, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Lactobacillus Ferment, Sophora Flavescens Root Extract, Lavandula Angustifolia (Lavender) Oil, Sodium Chloride

  • INACTIVE INGREDIENT

    Water, etc.

  • PURPOSE

    It is one-time female cleaner contained subacidity fermentation extract and natural origin and, hygienic and easy to use.
    It can help such as improvement odor, skin care, supply moisture and, pH balance.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    After washing hands, opening individual packaging and removing the Y cap.

    And then applying it to the required area.

    Panty-liner is recommended outside.

  • WARNINGS

    1. In case of having side effects such as red rash, swollenness and /or itching while using this cosmetic, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately.
    2. Do not apply it on the part where you have a scar, eczema or dermatitis.
    3. Precautions for treatment and storage.
      - Keep it out of the reach of children.
      - Avoid the place where the direct sunlight is.
  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LACTO BELLA Y 
    lactobacillus ferment, sophora flavescens root extract, lavandula angustifolia (lavender) oil, sodium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72280-0001
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE) (LACTOBACILLUS REUTERI - UNII:9913I24QEE) LACTOBACILLUS REUTERI0.6 g  in 100 mL
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT0.0015 g  in 100 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8) LAVENDER OIL0.8 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72280-0001-18 in 1 CARTON04/27/2018
    11.8 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/27/2018
    Labeler - Bella Lab Co., Ltd. (694921379)
    Registrant - Bella Lab Co., Ltd. (694921379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sphere Tech Co.,Ltd.689907467manufacture(72280-0001) , pack(72280-0001) , label(72280-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bella Lab Co., Ltd.694921379relabel(72280-0001)