Genteal Tears Gel
FDA Label NDC 0065-8064

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 (NDC 0065-8064). 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, otc - stop use, otc - 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 ingredientPurpose
Hypromellose 0.3%. Lubricant

Uses

  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
  • as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do Not Use

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

When Using This Product

  • do not touch tip of container to any surface
  • replace cap after using

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children


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 between 15° - 25°C (59° - 77°F)

Inactive Ingredients

carbopol 980, phosphonic acid, purified water, sodium hydroxide, sodium perborate, and sorbitol

Questions?

In the U.S., call toll-free
1-800-757-9195
(Mon-Fri 9AM-5PM CST)
[email protected]

Principal Display Panel

Severe DRY EYE SYMPTOM RELIEF
GEL

GenTeal® Tears
LUBRICANT EYE GEL

GEL
Delivers Long-lasting relief of dry eye symptoms  

STERILE
10 g (0.34 FL OZ)

TAMPER EVIDENT:
For your protection, use only if pull tab is intact at time of purchase.

Distributed by: 
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
A Novartis Division 

Lot/Exp

Alcon

25368102 

Carton (Carton)

Carton (Carton)



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