Theratears Extra Solution/ Drops
FDA Label NDC 58790-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc for the product Theratears Extra (NDC 58790-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium carboxymethylcellulose 0.25%

Purpose

Eye lubricant

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.

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 right away.

Directions

Instill 1 or 2 drops of TheraTears® Extra in the affected eye(s) as needed.

Other Information

  • Do not use if neck ring is broken or missing.

Inactive Ingredients

Boric acid, calcium chloride, Dequest®, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, magnesium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

Questions Or Comments?

1-800-579-8327

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 58790-007-15

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

0.5 FL OZ (15mL)

Principal Display Panel Text for Carton Label:

new!

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

STERILE

Multi-Use

Bottle* 0.5 FL OZ (15mL)

* Please review the disclaimer below.