Theratears Extra Solution/ Drops
FDA Label NDC 58790-010

12 label sections · Submitted to the FDA by Medtech Products Inc · 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 58790-010). 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.
    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.

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

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

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