GENTEAL TEARS (MILD)- dextran 70 and hypromellose 2910 solution/ drops

GenTeal Tears (Mild) by

Drug Labeling and Warnings

GenTeal Tears (Mild) by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Uses

• temporary relief of burning and irritation due to dryness of the eye
• temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
• as a protectant against further irritation

Warnings

For external use only

Do not use

• if 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
• replace cap after using

STOP USE

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 at room temperature

Inactive ingredients:

POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium borate and 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

NDC: 0065-0418-81

Mild DRY EYE SYMPTOM RELIEF

GenTeal* Tears

LUBRICANT EYE DROPS

LIQUID DROPS

Soothing Relief

PREVIOUSLY TEARS NATURALE* II

STERILE 15 mL (0.5 FL OZ)

Alcon®

TAMPER EVIDENT:
For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

GenTeal* Tears Mild Lubricant Eye Drops contains POLYQUAD* preservative, a safe and comfortable preservative, gentle enough for even sensitive eyes.

Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
a Novartis company

Country of Origin: USA

© 2015, 2016 Novartis

*trademark of Novartis

ACTUAL SIZE

9013370-0716

LOT:

EXP.:

NDC: 0065-0418-81

Mild DRY EYE SYMPTOM RELIEF

GenTeal* Tears

LUBRICANT EYE DROPS

LIQUID DROPS

Soothing Relief

STERILE 15 mL (0.5 FL OZ)

STERILE – FOR TOPICAL EYE USE ONLY

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Store at room temperature.

Alcon®

Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

© 2015, 2016 Novartis

*trademark of Novartis

LOT/EXP.:

H14443-0716

INGREDIENTS AND APPEARANCE

GENTEAL TEARS (MILD)  
dextran 70 and hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0418
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35)	Hypromellose 2910 (4000 Mpa.s)	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0418-81	1 in 1 CARTON	03/01/2016
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-0418-80	2 in 1 CARTON	03/01/2016
2		15 mL in 1 BOTTLE, DROPPER; 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	03/01/2016

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0418)