Label: TOPCARE HEALTH ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution
- NDC Code(s): 36800-972-01
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Stop use and ask a doctor if you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye or if the condition worsens or perists for more than 72 hours
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE HEALTH ARTIFICIAL TEARS
polyvinyl alcohol, povidone solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-972 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED 0.5 g in 100 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 0.6 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BICARBONATE (UNII: 8MDF5V39QO) DEXTROSE (UNII: IY9XDZ35W2) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-972-01 1 in 1 CARTON 01/31/2020 1 15 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 Drug M018 01/31/2020 Labeler - Topco Associates LLC (006935977) Registrant - K.C. Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations K.C. Pharmaceuticals, Inc. 174450460 manufacture(36800-972) , pack(36800-972) , label(36800-972)