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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Active Ingredients

Polyvinyl Alcohol 1.4%.

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.

Use as directed by your doctor or pharmacist

PRINCIPAL DISPLAY PANEL

Tears Renewed Lubricant Eye Drops

Relabeled By Preferred Pharmaceuticals, Inc
Anaheim, CA 92807

Akwa Tears Lubricant Eye Drops

AKWA TEARS 
polyvinyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0697(NDC:17478-060)
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
SODIUM HYDROXIDE 
WATER 
EDETATE DISODIUM 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:68788-0697-115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/22/2010
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-0697)

Revised: 03/2013
Document Id: 94cd7474-aac7-42f9-8d27-71a5db978f5c
Set id: 7f70dcc3-edd4-4440-866e-3b38ce246bab
Version: 5
Effective Time: 20130304
 
Preferred Pharmaceuticals, Inc