Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

TEARS NATURALE FREE- dextran 70, 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

• 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 product 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 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?               

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

PRINCIPAL DISPLAY PANEL

Mild/Moderate Dry Eye

Preservative Free

TEARS Naturale FREE®

LUBRICANT EYE DROPS  

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

STERILE
Alcon®

TEARS NATURALE FREE 
dextran 70, hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-5060
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: 0065-5060-09	36 in 1 CARTON	11/01/1990	06/30/2018
1		.8 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 0065-5060-10	60 in 1 CARTON	11/09/1999	04/30/2018
2		.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	06/30/2018

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Pharma Solutions, LLC		043911403	manufacture(0065-5060)

Revised: 12/2017

Document Id: f6264578-6243-4c48-927d-c57616c15b33

34390-5

Set id: 078001f6-16ef-449c-bfaf-2b0fcfb5e18a

Version: 2

Effective Time: 20171207