Medication Guide App

Tears Renewed Lubricant Eye Drops

Generic Name: dextran 70 and hypromelloses solution
Dosage Form: eye drops

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.

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.

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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 Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:68788-039-01 15 mL in 1 BOTTLE, DROPPER
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: 11/2010
 
Preferred Pharmaceuticals, Inc



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