Drug Facts

Active ingredient (In each unit dose)

sodium carboxymethylcellulose 1%

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. 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.

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

To open, twist tab completely off.
Instill 1 or 2 drops 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

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

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®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

30 STERILE

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

PRESERVATIVE
FREE
RECOMMENDED
DOCTOR
CREATED
thera
tears®
THERAPY FOR YOUR EYES®
Liquid Gel
nighttime
dry eye therapy
LUBRICANT EYE GEL
SOOTHING
OVERNIGHT
RELIEF
30 STERILE
Single-Use Vials* 0.60 FL OZ (18.0 mL) TOTAL

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

PRESERVATIVE
FREE
RECOMMENDED
DOCTOR
CREATED
thera
tears®
THERAPY FOR YOUR EYES®
Liquid Gel
nighttime
dry eye therapy
LUBRICANT EYE GEL
SOOTHING
OVERNIGHT
RELIEF
4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

THERATEARS
carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-002
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium, unspecified form	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	12/01/2002

THERATEARS
carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-003
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium, unspecified form	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	12/07/2018

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratoire Unither		574139809	label(58790-002, 58790-003) , manufacture(58790-002, 58790-003) , pack(58790-002, 58790-003)

TheraTears Liquid Night PF 58790-003

Active ingredient (In each unit dose)

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Principal Display Panel Text for Carton Label:

Principal Display Panel Text for Carton Label: