GenTeal Tears

Dextran 70, Glycerin, Hypromellose · Solution/ Drops · Ophthalmic

Over the counter Non-Standardized Chemical Allergen Plasma Volume Expander 1 recall

Active ingredient

Active ingredient Purpose Hypromellose 0.3%. Lubricant

Purpose

Active ingredient Purpose Hypromellose 0.3%. Lubricant

Uses

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

Warnings For external use only

Do not use

Do not use if gel changes color or becomes cloudy if you are sensitive to any ingredient in this product

When using this product

When using this product do not touch tip of container to any surface replace cap after using

Stop use and ask a doctor

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

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

Questions?

Questions? In the U.S., call toll-free 1-800-757-9195 ( Mon-Fri 9AM-5PM CST) alcon.medinfo@alcon.com

Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Dec 14, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

GenTeal Tears NDC products (2)

NDCStrength & formLabelerType
50090-5050Dextran 70 1 mg/mL; Glycerin 2 mg/mL; Hypromelloses 3 mg/mL
Solution/ Drops
A-S Medication SolutionsOTC MONOGRAPH DRUG
0065-8064Hypromellose 2910 (4000 Mpa.s) .003 g/g
Gel
Alcon Laboratories, Inc.OTC MONOGRAPH DRUG

GenTeal Tears recalls

Frequently asked questions

What is GenTeal Tears used for?

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

Who makes GenTeal Tears?

GenTeal Tears is listed by 2 labelers in the FDA NDC directory, including A-S Medication Solutions, Alcon Laboratories, Inc..

Has GenTeal Tears been recalled?

The FDA enforcement database lists 1 recall for GenTeal Tears, most recently D-0492-2026 (class ii): Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.