theratears extra pf 58790-010

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

Medication Information

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.

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.

Purpose

Eye lubricant

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.

Description

Drug Facts

Section 42229-5

Drug Facts

Do Not Use

if solution changes color or becomes cloudy.

Active Ingredient

Sodium carboxymethylcellulose 0.25%

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

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.

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.

Purpose

Eye lubricant

Directions

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

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.

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)

if solution changes color or becomes cloudy.

Active Ingredient (Active ingredient)

Sodium carboxymethylcellulose 0.25%

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

[{"name": "Carboxymethylcellulose", "unii": "05JZI7B19X", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "Boric Acid", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "calcium chloride", "unii": "M4I0D6VV5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "hydrochloric acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium chloride", "unii": "02F3473H9O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "potassium chloride", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium bicarbonate", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium borate", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium chloride", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium phosphate", "unii": "SE337SVY37", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "trehalose", "unii": "B8WCK70T7I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "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": "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"}

theratears extra pf 58790-010

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information