GENTEAL TEARS (MILD)- dextran 70 and hypromellose 2910 solution/ drops
Alcon Laboratories, Inc.

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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Drug Facts

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 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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0065-0418-81	1 in 1 CARTON	03/01/2016	02/28/2021
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	02/28/2021
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/01/2016	02/28/2021

Labeler - Alcon Laboratories, Inc. (008018525)

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

Revised: 5/2021

Document Id: 462c5403-3746-421b-bbfc-d067a5780de6

Set id: a1c43ff3-c16a-c58b-d61a-2e3c2abfd496

Version: 9

Effective Time: 20210528

Alcon Laboratories, Inc.