Label: FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS- povidone, polyvinyl alcohol solution
- NDC Code(s): 71776-001-03, 71776-001-10
- Packager: Eyevance Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 5, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS
povidone, polyvinyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71776-001 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:71776-001-10 1 in 1 BOX 03/13/2019 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:71776-001-03 30 in 1 BOX 12/06/2020 2 0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M018 03/13/2019 Labeler - Eyevance Pharmaceuticals (080876046) Establishment Name Address ID/FEI Business Operations ExcelVision 274234566 manufacture(71776-001) , pack(71776-001)