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Name:Akwa Tears
Manufacturer:Preferred Pharmaceuticals, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

AKWA TEARS   - polyvinyl alcohol solution 
Preferred Pharmaceuticals, 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

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

image of Akwa Tears

Use as directed by your doctor or pharmacist


AKWA TEARS  
polyvinyl alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0697(NDC:17478-060)
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
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0697-1 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: 03/2011 Preferred Pharmaceuticals, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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