GENTEAL TEARS SEVERE- hypromellose gel

GenTeal Tears by

Drug Labeling and Warnings

GenTeal Tears by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Excelvision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• 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

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
  

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 15º - 25ºC (59º - 77ºF)

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)
alcon.medinfo@alcon.com

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 

INGREDIENTS AND APPEARANCE

GENTEAL TEARS   SEVERE
hypromellose gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-8064
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hypromellose 2910 (4000 Mpa.S) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.S) - UNII:RN3152OP35)	Hypromellose 2910 (4000 Mpa.S)	.003 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sodium Perborate (UNII: Y52BK1W96C)
Phosphonic Acid (UNII: 35V6A8JW8E)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Sorbitol (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-8064-01	1 in 1 CARTON	12/14/2019
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/14/2019

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	manufacture(0065-8064) , label(0065-8064) , pack(0065-8064)