Theratears Lubricant Solution/ Drops
FDA Label NDC 58790-001

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 Lubricant (NDC 58790-001). 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 other, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Sodium carboxy-
methylcellulose 0.25%

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. 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Do not use if imprinted neckband is broken or missing.

Inactive Ingredients

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

Questions Or Comments?

1-800-579-8327

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES™

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

1 FL OZ (30 mL)

Principal Display Panel Text for Carton Label:

VALUE SIZE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

STERILE

Multi-Use Bottle*

1 FL OZ (30 mL)

* Please review the disclaimer below.