GENTEAL SEVERE- hypromellose gel
Novartis Pharmaceuticals Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 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 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

GENTEAL SEVERE
hypromellose gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0078-0429
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/14/2009	08/31/2021

Labeler - Novartis Pharmaceuticals Corporation (002147023)

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

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

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

Revised: 1/2020

Document Id: 2f179d51-adb1-43f8-b17e-bebff4c0fe84

Set id: 864d7ade-e399-4871-b7dc-e0594246b0a7

Version: 11

Effective Time: 20200107

Novartis Pharmaceuticals Corporation