Label: THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops
- NDC Code(s): 58790-001-15, 58790-001-30, 58790-001-31
- Packager: MEDTECH PRODUCTS INC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 8, 2022
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INGREDIENTS AND APPEARANCE
THERATEARS LUBRICANT
carboxymethylcellulose sodium solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58790-001 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength boric acid (UNII: R57ZHV85D4) sodium perborate (UNII: Y52BK1W96C) calcium chloride (UNII: M4I0D6VV5M) diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) water (UNII: 059QF0KO0R) sodium bicarbonate (UNII: 8MDF5V39QO) sodium chloride (UNII: 451W47IQ8X) sodium phosphate (UNII: SE337SVY37) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58790-001-30 1 in 1 CARTON 07/01/1999 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:58790-001-15 1 in 1 CARTON 07/01/1999 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:58790-001-31 2 in 1 CARTON 12/01/2020 3 30 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 07/01/1999 Labeler - MEDTECH PRODUCTS INC (114707784) Establishment Name Address ID/FEI Business Operations Akorn AG 482198285 analysis(58790-001) , label(58790-001) , manufacture(58790-001) , pack(58790-001) Establishment Name Address ID/FEI Business Operations Akorn Operating Company LLC (dba Akorn) 117696790 label(58790-001) , pack(58790-001) Establishment Name Address ID/FEI Business Operations Akorn Operating Company LLC (dba Akorn) 117696832 analysis(58790-001) , manufacture(58790-001) , sterilize(58790-001)