NDC | 15821-108-10 |
Set ID | ae2faac0-ca34-4d9b-89fd-fb889060f744 |
Category | HUMAN OTC DRUG LABEL |
Packager | FOCUS Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FRESHKOTE PRESERVATIVE FREE LUBRICATING EYE DROPS
povidone, polyvinyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15821-108 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 20 g in 1000 mL POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED 27 g in 1000 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15821-108-10 1 in 1 BOX 06/29/2018 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 06/29/2018 Labeler - FOCUS Laboratories, Inc. (926378337) Establishment Name Address ID/FEI Business Operations ExcelVision 274234566 manufacture(15821-108) , pack(15821-108)