NDC | 72280-0001-1 |
Set ID | 6ace64f4-2843-98eb-e053-2991aa0a23cb |
Category | HUMAN OTC DRUG LABEL |
Packager | Bella Lab Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
-
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)