Theratears Gel
FDA Label NDC 58790-003

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 (NDC 58790-003). 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 (in each unit dose), 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 (In Each Unit Dose)

sodium carboxymethylcellulose 1%

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. 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 be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

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

  • To open, twist tab completely off.
  • Instill 1 or 2 drops 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

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

Otc - Questions

Questions or comments?        1-800-579-8327

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

STERILE

4 Single-Use

Vials 0.08 FL OZ (2.4mL) TOTAL

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

28 STERILE

Single-Use Vials* 0.57 FL OZ (16.8mL) TOTAL

* Please review the disclaimer below.