Theratears Liquid Night Pf 58790-003

Theratears Liquid Night Pf 58790-003
SPL v11
SPL
SPL Set ID 17a01236-130f-495b-9f8d-92b6a23b2dc5
Route
OPHTHALMIC
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (10 mg)
Inactive Ingredients
Boric Acid Sodium Borate Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Bicarbonate Sodium Chloride Sodium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-07

Description

Drug Facts

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Drug Facts

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.
Section 42229-5

Drug Facts

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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use
  • If solution changes color or becomes cloudy.
Other Information
  • Store between 15C-25C (59F-77F)

  • Do not touch unit-dose tip to eye.
Inactive Ingredients

boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium phosphate, water 

Questions or comments?        1-800-579-8327

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.

Active Ingredient (in Each Unit Dose)

sodium carboxymethylcellulose 1%

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Purpose

Eye lubricant

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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use (Do not use)
  • If solution changes color or becomes cloudy.
Other Information (Other information)
  • Store between 15C-25C (59F-77F)

  • Do not touch unit-dose tip to eye.
Inactive Ingredients (Inactive ingredients)

boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium phosphate, water 

Questions or comments?        1-800-579-8327

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Active Ingredient (in Each Unit Dose) (Active ingredient (In each unit dose))

sodium carboxymethylcellulose 1%

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


Advanced Ingredient Data


Raw Label Data

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