TEARS NATURALE FREE- dextran 70, hypromellose 2910 solution/ drops

Tears Naturale Free by

Drug Labeling and Warnings

Tears Naturale Free by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Kaysersberg Pharmaceuticals, Catalent Pharma Solutions, 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

PURPOSE

Uses

• For the 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 eye pain.
• you experience changes in vision.
• you experience continued redness or irritation of the eye.
• the 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

• Instill one or two drops in the affected eye(s) as needed.

Other information

• Store at room temperature.

Inactive Ingredients

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

Questions or Comments? Call Us.

In the U.S. call 1 (800) 757-9195 or visit www.tearsnaturale.com 

TEARS Naturale FREE® LUBRICANT EYE DROPS PERFORMANCE GUARANTEE (see side panel)

PRINCIPAL DISPLAY PANEL

Mild/Moderate Dry Eye

Preservative Free

TEARS Naturale FREE®

LUBRICANT EYE DROPS

60 Single-Use Vials
0.9 mL (0.03 FL OZ Each

STERILE

Alcon®

Convenience
Tears Naturale Free® Lubricant Eye Drops provide lasting relief for mild to moderate dry eye with the convenience of a vial.

Guaranteed to provide relief.
TEARS NATURALE FREE® Lubricant Eye Drops is guaranteed to provide temporary relief of dry eye symptoms. Prove it to yourself at no risk. If TEARS NATURALE FREE® Lubricant Eye Drops does not provide you with the relief you expect, you may return the unused portion with evidence of price paid to
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134, for an immediate and full refund.

TAMPER EVIDENT:
Do not use if vial is damaged or opened.
© 2002, 2003, 2006, 2008, 2012 Novartis

Manufactured for:
Alcon®
ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
MADE IN FRANCE

427294

9008140-0512
 
Preservative Free
TEARS Naturale FREE®
(Dextran 70 0.1% and Hypromellose 2910 0.3%)
LUBRICANT EYE DROP

DIRECTIONS:
Make sure container is intact before use.
To open, completely TWIST off tab.
Do NOT pull off.

Instill 1 or 2 drops in the affected eye(s) as needed.

Throw away container. Do not reuse.

See more information at www.tearsnaturale.com

INGREDIENTS AND APPEARANCE

TEARS NATURALE FREE 
dextran 70, hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0416
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: 0065-0416-22	60 in 1 CARTON	11/01/1990	02/29/2020
1		.9 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 0065-0416-25	36 in 1 CARTON	11/01/1990	02/29/2020
2		.9 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3	NDC: 0065-0416-36	60 in 1 CARTON	03/01/2002	02/29/2020
3		.8 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	11/01/1990	02/29/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-0416)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		043911403	MANUFACTURE(0065-0416)