THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified solution/ drops

TheraTears Extra by

Drug Labeling and Warnings

TheraTears Extra by is a Otc medication manufactured, distributed, or labeled by MEDTECH PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium carboxymethylcellulose 0.25%

Purpose

Eye lubricant

Uses

• For use as a protectant against further irritation or to relieve dryness of the eye.
  
• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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.

Do not use

• if solution changes color or becomes cloudy.

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• To open, twist tab completely off.
  
• Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed

Other information

• Use only if foil pouch is sealed and single-use container is intact.
  
• Do not touch unit-dose tip to eye.

Inactive ingredients

Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

30 STERILE

Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL

INGREDIENTS AND APPEARANCE

THERATEARS EXTRA 
carboxymethylcellulose sodium, unspecified solution/ drops

Product 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)