Label: THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified solution/ drops
- NDC Code(s): 58790-010-30
- Packager: MEDTECH PRODUCTS 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.
Drug Label Information
Updated March 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
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 he 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel Text for Carton Label:
-
INGREDIENTS AND APPEARANCE
THERATEARS EXTRA
carboxymethylcellulose sodium, unspecified solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58790-010 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Boric Acid (UNII: R57ZHV85D4) calcium chloride (UNII: M4I0D6VV5M) hydrochloric acid (UNII: QTT17582CB) magnesium chloride (UNII: 02F3473H9O) potassium chloride (UNII: 660YQ98I10) sodium bicarbonate (UNII: 8MDF5V39QO) sodium borate (UNII: 91MBZ8H3QO) sodium chloride (UNII: 451W47IQ8X) sodium hydroxide (UNII: 55X04QC32I) sodium phosphate (UNII: SE337SVY37) trehalose (UNII: B8WCK70T7I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58790-010-30 6 in 1 CARTON 01/21/2021 1 5 in 1 POUCH 1 0.6 mL in 1 VIAL, SINGLE-USE; 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 01/21/2021 Labeler - MEDTECH PRODUCTS INC (114707784)