GENTEAL MILD- hypromellose liquid

GenTeal by

Drug Labeling and Warnings

GenTeal by is a Otc medication manufactured, distributed, or labeled by Novartis Pharmaceutical Corporation, EXCELVISION AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use

• 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

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

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)

INGREDIENTS AND APPEARANCE

GENTEAL  MILD
hypromellose liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0078-0517
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)	200 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Calcium Chloride (UNII: M4I0D6VV5M)
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: 0078-0517-24	.015 L in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/14/2009	10/31/2017
2	NDC: 0078-0517-16	.025 L in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/14/2009

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(0078-0517)