TEARS NATURALE II POLYQUAD- dextran 70, hypromellose 2910 solution
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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Tears Naturale II POLYQUAD

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose
Dextran 70 0.1%	Lubricant
Hypromellose 2910 0.3%	Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye
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
replace cap after using
remove contact lenses before 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%, 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

PRINCIPAL DISPLAY PANEL

Mild/Moderate Dry Eye

Soothing Comfort

Tears Naturale®II
Polyquad®

LUBRICANT EYE DROPS

15mL
(0.5 FL OZ)

STERILE
Alcon®

TEARS NATURALE II POLYQUAD
dextran 70, hypromellose 2910 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-5040
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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:0065-5040-15	1 in 1 CARTON	11/10/2017	12/17/2019
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0065-5040-30	1 in 1 CARTON	11/10/2017	12/17/2019
2		30 mL in 1 BOTTLE; 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	11/10/2017	12/17/2019

Labeler - Alcon Laboratories, Inc. (008018525)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Research LLC		007672236	manufacture(0065-5040)

Revised: 12/2019

Document Id: 6d8e0f20-9437-4969-80a9-c2c437812d6b

Set id: 9d4fb589-2357-4d07-8ba9-d55663a7446b

Version: 2

Effective Time: 20191226

Alcon Laboratories, Inc.