Label: THERATEARS- carboxymethylcellulose sodium gel
- NDC Code(s): 58790-002-28, 58790-003-30
- Packager: MEDTECH PRODUCTS INC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 22, 2022
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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
- Principal Display Panel Text for Carton Label:
- 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 final part349 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 final part349 12/07/2018 Labeler - MEDTECH PRODUCTS INC (114707784) Establishment Name Address ID/FEI Business Operations Laboratoire Unither 574139809 label(58790-002, 58790-003) , manufacture(58790-002, 58790-003) , pack(58790-002, 58790-003)