Genteal Tears Moderate Preservative Free Solution/ Drops
FDA Label NDC 0065-8063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Genteal Tears Moderate Preservative Free (NDC 0065-8063). 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 otc - purpose, uses, warnings, do not use, when using this product, 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

Otc - Purpose

Active IngredientsPurpose
Dextran 70 0.1%Lubricant
Hypromellose 2910 0.3%Lubricant

Uses

  • temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

For external use only

Do Not Use

  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When Using This Product

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

Stop Use And Ask A Doctor If

you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • 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

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

Other Information

  • store are room temperature 15o – 25o C (59o – 77o F)

Inactive Ingredients

potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

PRESERVATIVE FREE

Moderate DRY EYE SYMPTOM RELIEF

GenTeal* Tears
LUBRICANT EYE DROPS

LIQUID DROPS

Fast, Soothing Relief
Preservative Free Formula

Previously TEARS NATURALE* FREE LUBRICANT EYE DROPS

STERILE  36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each

Alcon®

GenTeal* Tears Lubricant Eye Drops
Preservative Free provide lasting relief
for moderate dry eye with the
convenience of a vial.

TAMPER EVIDENTY:
Do not use if vial is damaged or opened.

Distributed by:
Alcon Laboratories, Inc.,
6201 South Freeway
Fort Worth, Texas 76134
a Novartis company

Country of Origin: France

© 2015 Novartis
*trademark of Novartis

435580

W9012667-1115

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