GENTEAL  MILD TO MODERATE- hypromellose 2910 (4000 mpa.s) liquid 
Novartis Pharmaceutical 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.

----------

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Hypromellose (0.3%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Put 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

Store between 15°- 25°C (59°- 77°F).

INACTIVE INGREDIENT SECTION

Boric acid, phosphonic acid, potassium chloride, purified water, sodium chloride and sodium perborate. May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

In the U.S.,call toll-free 1-866-393-6336;
MedInfo@AlconLabs.com
Serious side effects associated with use of this product may be reported to this telephone number.
www.genteal.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0078-0518-2
Mild to Moderate
Dry Eye Relief

GenTeal®
LUBRICANT EYE DROPS

LIQUID DROPS
Fast, Soothing Relief

Alcon®
STERILE 15 mL (0.5 fl oz)

Carton
GENTEAL   MILD TO MODERATE
hypromellose liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0518
Route of Administration OPHTHALMIC DEA Schedule     
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) 0.003 L  in 1 L
Inactive Ingredients
Ingredient Name Strength
Boric Acid (UNII: R57ZHV85D4)  
Phosphonic Acid (UNII: 35V6A8JW8E)  
Potassium Chloride (UNII: 660YQ98I10)  
Water (UNII: 059QF0KO0R)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Perborate (UNII: Y52BK1W96C)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0078-0518-24 .015 L in 1 BOTTLE, DROPPER
2 NDC:0078-0518-16 .025 L in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 09/14/2009
Labeler - Novartis Pharmaceutical Corporation (002147023)
Establishment
Name Address ID/FEI Business Operations
EXCELVISION AG 482198285 MANUFACTURE(0078-0518)

Revised: 9/2012
Document Id: f9a7c50d-feb8-375d-cc86-1a779df24eea
Set id: dfcc80aa-aee3-4e9a-b844-12ffcd872cae
Version: 3
Effective Time: 20120917
 
Novartis Pharmaceutical Corporation