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 ingredientsPurpose
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

15 mL Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0065-5040
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 701 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0065-5040-151 in 1 CARTON11/10/201712/17/2019
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 0065-5040-301 in 1 CARTON11/10/201712/17/2019
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/10/201712/17/2019
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-5040)

Revised: 12/2019