GENTEAL TEARS MODERATE PRESERVATIVE FREE- dextran 70, hypromellose 2910 solution/ drops

GenTeal Tears Moderate Preservative Free by

Drug Labeling and Warnings

GenTeal Tears Moderate Preservative Free by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Kaysersberg Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Dextran 70 0.1%: Lubricant
• Hypromellose 2910 0.3%: Lubricant

PURPOSE

Uses

• temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

For external use only

Do not use

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

When using this product

• to avoid contamination, do not touch tip of container to any surface
• do not reuse
• once opened, discard

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 are room temperature 15o – 25o C (59o – 77o F)

Inactive ingredients

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

Questions?               

In the U.S. call 1 (800) 757-9195 (Mon-Fri 9AM-5PM CST)
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

PRESERVATIVE FREE

Moderate DRY EYE SYMPTOM RELIEF

GenTeal* Tears
LUBRICANT EYE DROPS

LIQUID DROPS

Fast, Soothing Relief
Preservative Free Formula


Previously TEARS NATURALE* FREE LUBRICANT EYE DROPS

STERILE  36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each

Alcon®

PRESERVATIVE FREE

Moderate DRY EYE SYMPTOM RELIEF

GenTeal* Tears
LUBRICANT EYE DROPS

LIQUID DROPS

Fast, Soothing Relief
Preservative Free Formula

Previously TEARS NATURALE* FREE LUBRICANT EYE DROPS

STERILE  36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each

Alcon®

GenTeal* Tears Lubricant Eye Drops
Preservative Free provide lasting relief
for moderate dry eye with the
convenience of a vial.

TAMPER EVIDENTY:
Do not use if vial is damaged or opened.

Distributed by:
Alcon Laboratories, Inc.,
6201 South Freeway
Fort Worth, Texas 76134
a Novartis company

Country of Origin: France

© 2015 Novartis
*trademark of Novartis

435580

W9012667-1115

INGREDIENTS AND APPEARANCE

GENTEAL TEARS MODERATE PRESERVATIVE FREE 
dextran 70, hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-8063
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)	3 mg  in 1 mL
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-8063-01	36 in 1 CARTON	12/22/2017
1		.9 mL in 1 VIAL, SINGLE-DOSE; 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	12/22/2017

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		043911403	manufacture(0065-8063)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-8063)