THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops

TheraTears Lubricant by

Drug Labeling and Warnings

TheraTears Lubricant 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 carboxy-
methylcellulose 0.25%

Purpose

Eye lubricant

Uses

• As a lubricant to relieve dryness of the eye.
• As a protectant against further irritation of the eye.
• For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Warnings

For external use only

• To avoid contamination do not touch tip of opened container to any surface. Replace cap after using.

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 immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Do not use if imprinted neckband is broken or missing.

Inactive ingredients

Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium perborate, and sodium phosphate

Questions or comments?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES™

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

VALUE SIZE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

STERILE

Multi-Use Bottle*

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58790-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
boric acid (UNII: R57ZHV85D4)
sodium perborate (UNII: Y52BK1W96C)
calcium chloride (UNII: M4I0D6VV5M)
diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3)
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: 58790-001-30	1 in 1 CARTON	07/01/1999
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 58790-001-15	1 in 1 CARTON	07/01/1999
2		15 mL in 1 BOTTLE, DROPPER; 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	07/01/1999

Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(58790-001) , LABEL(58790-001)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		155135783	MANUFACTURE(58790-001) , ANALYSIS(58790-001) , STERILIZE(58790-001)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	manufacture(58790-001) , pack(58790-001) , analysis(58790-001)