Label: THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops
- NDC Code(s): 58790-000-20, 58790-000-24, 58790-000-30, 58790-000-32
- Packager: Advanced Vision Research (Subsidiary of Akorn, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 8, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (In each unit dose)
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 ptential contamination during handling.
Stop use and ask a doctor if
- You experience eye pain, changes in vision, continued redness or irritation.
- Condition worsens or persists for more than 72 hours.
- Other information
- Inactive ingredients
- Questions and comments?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
carboxymethylcellulose sodium solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58790-000 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 2.5 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:58790-000-32 8 in 1 CARTON 01/01/1995 1 4 in 1 POUCH 1 19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:58790-000-24 6 in 1 CARTON 01/01/1995 2 4 in 1 POUCH 2 19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product 3 NDC:58790-000-20 5 in 1 CARTON 01/01/1995 3 4 in 1 POUCH 3 19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product 4 NDC:58790-000-30 5 in 1 CARTON 12/07/2018 4 6 in 1 POUCH 4 0.6 mL in 1 APPLICATOR; 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 01/01/1995 Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (117696736) Registrant - Akorn Operating Company LLC (117693100)