GENTEAL SEVERE- hypromellose gel

GenTeal by

Drug Labeling and Warnings

GenTeal by is a Otc medication manufactured, distributed, or labeled by Novartis Pharmaceuticals Corporation, Akorn AG, Excelvision, SERVIPACK. 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)

Alcon®

NDC: 0078-0429-47

Severe
DRY EYE SYMPTOM RELIEF
GEL

GenTeal® Tears
LUBRICANT EYE GEL

GEL
Delivers Long-lasting relief of dry eye symptoms  

New Design

STERILE
10 g (0.34 FL OZ)

Alcon®

Distributed by:
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134 USA
a Novartis Company
Country of Origin: Switzerland
© 2016 Novartis

INGREDIENTS AND APPEARANCE

GENTEAL  SEVERE
hypromellose gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0078-0429
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: 0078-0429-97	1 in 1 CARTON	09/14/2009	02/28/2015
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0078-0429-47	1 in 1 CARTON	09/14/2009	08/31/2021
2		10 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0078-0429-57	2 in 1 CARTON	09/14/2009	08/31/2019
3		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	09/14/2009	08/31/2021

Labeler - Novartis Pharmaceuticals Corporation (002147023)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	manufacture(0078-0429) , label(0078-0429) , pack(0078-0429)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	manufacture(0078-0429) , label(0078-0429) , pack(0078-0429)

Establishment
Name	Address	ID/FEI	Business Operations
SERVIPACK		571772875	label(0078-0429) , pack(0078-0429)