Label: LACTO BELLA Y (lactobacillus ferment, sophora flavescens root extract, lavandula angustifolia- lavender oil, sodium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72280-0001-1 - Packager: Bella Lab Co., Ltd.
- 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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
- 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.
- Do not apply it on the part where you have a scar, eczema or dermatitis.
- Precautions for treatment and storage.
- Keep it out of the reach of children.
- Avoid the place where the direct sunlight is.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LACTO BELLA Y
lactobacillus ferment, sophora flavescens root extract, lavandula angustifolia (lavender) oil, sodium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72280-0001 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS REUTERI (UNII: 9913I24QEE) (LACTOBACILLUS REUTERI - UNII:9913I24QEE) LACTOBACILLUS REUTERI 0.6 g in 100 mL SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT 0.0015 g in 100 mL LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8) LAVENDER OIL 0.8 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72280-0001-1 8 in 1 CARTON 04/27/2018 1 1.8 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/27/2018 Labeler - Bella Lab Co., Ltd. (694921379) Registrant - Bella Lab Co., Ltd. (694921379) Establishment Name Address ID/FEI Business Operations Sphere Tech Co.,Ltd. 689907467 manufacture(72280-0001) , pack(72280-0001) , label(72280-0001) Establishment Name Address ID/FEI Business Operations Bella Lab Co., Ltd. 694921379 relabel(72280-0001)