OTC Medication Information: Akwa Tears

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.

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
(click image for full-size original)
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 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC
SODIUM HYDROXIDE
WATER
EDETATE DISODIUM
BENZALKONIUM CHLORIDE
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 (68788-0697)

Revised: 03/2013 Preferred Pharmaceuticals, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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