Theratears Extra Pf 58790-010

Theratears Extra Pf 58790-010
SPL v4
SPL
SPL Set ID f1845041-9d8d-42a0-a2cb-68def7a5aac7
Route
OPHTHALMIC
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (2.5 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Hydrochloric Acid Magnesium Chloride Potassium Chloride Sodium Bicarbonate Sodium Borate Sodium Chloride Sodium Hydroxide Sodium Phosphate Trehalose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-21

Description

Drug Facts

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Drug Facts

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.
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 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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
Do Not Use
  • if solution changes color or becomes cloudy.
Active Ingredient

Sodium carboxymethylcellulose 0.25%

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

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.

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


Structured Label Content

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.
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 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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
Do Not Use (Do not use)
  • if solution changes color or becomes cloudy.
Active Ingredient (Active ingredient)

Sodium carboxymethylcellulose 0.25%

Other Information (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 (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? (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 right away.

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


Advanced Ingredient Data


Raw Label Data

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