AKWA TEARS  - polyvinyl alcohol solution 
Preferred Pharmaceuticals, Inc

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Drug Facts

Active Ingredients

Polyvinyl Alcohol 1.4%.

Benzalkonium Chloride 0.005%

Uses

• for the temporary relief of burning and irritation of the eye and for use as a protectant against further irritation.
• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
  

Warnings

• Do not use if imprinted seal on the bottle neck is broken or missing
• Do not use if solution changes color or becomes cloudy
• To avoid contamination, do not touch tip of container to any surface
• Replace cap after using
  

When using this product

• remove contact lenses before using
• to avoid contamination, do not touch tip
  
• replace cap after each use.

Other Information

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
•  Store away from heat.
•  Protect from freezing.
• Keep tightly closed.
  

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye gets worse or lasts more than 72 hours.
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Store at room temperature.
  

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium
Phosphate Monobasic, Purified Water, USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

PRINCIPAL DISPLAY PANEL

Tears Renewed Lubricant Eye Drops

Relabeled By Preferred Pharmaceuticals, Inc
Anaheim, CA 92807

Use as directed by your doctor or pharmacist

AKWA TEARS  polyvinyl alcohol   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68788-697 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL .014 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE   SODIUM PHOSPHATE, DIBASIC   SODIUM PHOSPHATE, MONOBASIC   SODIUM HYDROXIDE   WATER   EDETATE DISODIUM   BENZALKONIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68788-697-01 15 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/22/2010

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Operations
Preferred Pharmaceuticals, Inc		791119022	relabel, repack

Establishment
Name	Address	ID/FEI	Operations
Akorn, Inc		155135783	manufacture

Revised: 11/2010Preferred Pharmaceuticals, Inc