Tears Renewed Lubricant Eye Drops

Dosage Form: eye drops
Drug Facts

Active Ingredients

Dextran 70 (0.1%)...........................................................(Lubricant)

Hypromellose 2910 (0.3%)...............................................(Lubricant)

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

For external use only.  Do not use: if this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

When using this product

• remove contact lenses before using


• to avoid contamination, do not touch tip
  


• replace cap after each use.
  

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.
  

Inactive Ingredients: Benzalkonium Chloride, Potassium Chloride, Disodium Chloride, Sodium Borate, Sodium Chloride, Boric Acid, Sterile Water, Purified Water, Sodium Chloride, and Sodium Citrate.

PRINCIPAL DISPLAY PANEL

Tears Renewed Lubricant Eye Drops

Relabeled By Preferred Pharmaceuticals, Inc

Anaheim, CA 92807

Use as directed by your doctor or pharmacist

TEARS RENEWED LUBRICANT EYEDROPS  dextran 70  solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68788-039 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (DEXTRAN 70) DEXTRAN 70 0.001 mL  in 1 mL HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES 0.003 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   POTASSIUM CHLORIDE   SODIUM BORATE   SODIUM CHLORIDE   BORIC ACID   WATER   SODIUM CITRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68788-039-01 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	11/16/2010

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

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