Tears Naturale II  POLYQUAD

Tears Naturale II Polyquad by

Drug Labeling and Warnings

Tears Naturale II Polyquad 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]

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

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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/10/2017	12/17/2019

Labeler - Alcon Laboratories, Inc. (008018525)

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

Revised: 12/2019

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

34390-5

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

Version: 2

Effective Time: 20191226