Label: THERATEARS- carboxymethylcellulose sodium gel
- NDC Code(s): 58790-002-28, 58790-003-30
- Packager: MEDTECH PRODUCTS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (In each unit dose)
- Purpose
- Uses
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Warnings
For external use only
- To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
- This product contains no preservatives. Any solution not used immediately after opening should be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.
- To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
- Directions
- Other information
- Inactive ingredients
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- Principal Display Panel Text for Carton Label:
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INGREDIENTS AND APPEARANCE
THERATEARS
carboxymethylcellulose sodium gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58790-002 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium, unspecified form 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength boric acid (UNII: R57ZHV85D4) sodium borate (UNII: 91MBZ8H3QO) calcium chloride (UNII: M4I0D6VV5M) 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:58790-002-28 7 in 1 CARTON 12/01/2002 1 0.6 mL in 1 POUCH; 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 12/01/2002 THERATEARS
carboxymethylcellulose sodium gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58790-003 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium, unspecified form 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength boric acid (UNII: R57ZHV85D4) sodium borate (UNII: 91MBZ8H3QO) calcium chloride (UNII: M4I0D6VV5M) 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:58790-003-30 6 in 1 CARTON 12/07/2018 1 5 in 1 POUCH 1 0.6 mL in 1 VIAL; 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 12/07/2018 Labeler - MEDTECH PRODUCTS INC (114707784)


