GENTEAL TEARS (MODERATE)- dextran 70, glycerin, hypromellose solution/ drops

GenTeal Tears (Moderate) by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Dextran 70 0.1%: Lubricant
• Glycerin 0.2%: Lubricant
• Hypromellose 0.3%: Lubricant

Uses

• temporary relief of burning and irritation due to dryness of the eye
• as a protectant against further irritation
• 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

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

STOP USE

Stop use and ask a doctor if you experience any of the following:

• you feel 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:

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

Questions?

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

PRINCIPAL DISPLAY PANEL

NDC  0065-0426-36

Moderate DRY EYE SYMPTOM RELIEF

GenTeal* Tears
LUBRICANT EYE DROPS

LIQUID DROPS
Fast Soothing Relief

PREVIOUSLY TEARS NATURALE* FORTE

STERILE 15 mL (0.5 FL OZ)

Alcon®

INGREDIENTS AND APPEARANCE

GENTEAL TEARS (MODERATE)  
dextran 70, glycerin, hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0426
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
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	2 mg  in 1 mL
Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO)	Hypromelloses	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Calcium Chloride (UNII: M4I0D6VV5M)
Glycine (UNII: TE7660XO1C)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Magnesium Chloride (UNII: 02F3473H9O)
Polidronium Chloride (UNII: 6716Z5YR3G)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Zinc Chloride (UNII: 86Q357L16B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0426-36	1 in 1 CARTON	03/01/2016
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-0426-37	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(0065-0426)