Theratears Dry And Tired Solution/ Drops
FDA Label NDC 58790-013

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 Dry And Tired (NDC 58790-013). 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 (in each unit dose), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient (In Each Unit Dose)

Sodium Carboxymethylcellulose 0.5%

Purpose

Eye lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind and sun.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings

For use in the eyes only.

Do Not Use

if solution changes color or becomes cloudy.

When Using This Product

■ do not touch tip of container to any surface to avoid contamination.

■ do not reuse; once opened discard.

Stop Use And Ask A Doctor If

■ you experience eye pain, changes in vision, continued redness or irritation of the eye.

■ the 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

  • To open, twist tab completely off.
  • Instill 1 or 2 drops into affected eye(s) as needed and discard container.

Other Information

  • Store between 15°-30°C (59°-86°F).

Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions And Comments?

1-800-579-8327

Principal Display Panel

Carboxymethylcellulose sodium 0.5%

LUBRICANT EYE DROPS

DRY & TIRED

dry eye therapy

PRESERVATIVE FREE

30 STERILE

Single-Use Vials

0.4 FL OZ (12 mL) TOTAL

Principal Display Panelcarboxymethylcellulose Sodium 0.5%lubricant Eye Dropsdry & Tired Dry Eye Therapypreservative Free30 Sterile Single-use Vials0.4 Fl Oz (12 mL) Total (Theratears Dry And Tired Dry Eye Therapy Pf 5879 01)

Principal Display Panelcarboxymethylcellulose Sodium 0.5%lubricant Eye Dropsdry & Tired Dry Eye Therapypreservative Free30 Sterile Single-use Vials0.4 Fl Oz (12 mL) Total (Theratears Dry And Tired Dry Eye Therapy Pf 5879 01)

* Please review the disclaimer below.