GENTEAL MILD - 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.

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OTC - ACTIVE INGREDIENT SECTION

hypromellose (0.2%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

Relieves dryness of the eye.
Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product

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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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, calcium chloride dihydrate, 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

PRINCIPAL DISPLAY PANEL

NDC 0078-0517-24

Mild
Dry Eye Relief

GenTeal®
LUBRICANT EYE DROPS

LIQUID DROPS
Fast, Soothing Relief

Alcon®

STERILE 15 mL (0.5 fl oz)

GENTEAL MILD
hypromellose liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0078-0517
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hypromellose 2910 (4000 Mpa.s) (Hypromellose 2910 (4000 Mpa.s))	Hypromellose 2910 (4000 Mpa.s)	0.002 L in 1 L

Inactive Ingredients
Ingredient Name	Strength
Boric Acid
Calcium Chloride
Phosphonic Acid
Potassium Chloride
Water
Sodium Chloride
Sodium Perborate
Hydrochloric Acid
Sodium Hydroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0078-0517-24	.015 L in 1 BOTTLE, DROPPER	None
2	NDC:0078-0517-16	.025 L in 1 BOTTLE, DROPPER	None

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	Operations
EXCELVISION AG		482198285	MANUFACTURE

Revised: 07/2012 Novartis Pharmaceutical Corporation