NDC | 72293-0001-1 |
Set ID | 6b590c72-124d-6f45-e053-2991aa0a8af6 |
Category | HUMAN OTC DRUG LABEL |
Packager | BMONUMENT Co., Ltd |
Generic Name | |
Product Class | Adenosine Receptor Agonist |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WATERFUL ESSENCE SUN
octinoxate, homosalate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72293-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 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:72293-0001-1 50 mL in 1 TUBE; Type 0: Not a Combination Product 05/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/04/2018 Labeler - BMONUMENT Co., Ltd (694624625) Registrant - BMONUMENT Co., Ltd (694624625) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(72293-0001) , label(72293-0001) , pack(72293-0001) Establishment Name Address ID/FEI Business Operations BMONUMENT Co., Ltd 694624625 relabel(72293-0001)