TEARS RENEWED LUBRICANT- dextran 70 solution

Tears Renewed Lubricant by

Drug Labeling and Warnings

Tears Renewed Lubricant by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

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

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

PURPOSE

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

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

When using this product

• remove contact lenses before using
• to avoid contamination, do not touch tip
  
• replace cap after each use.
  

STOP 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.
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Store at room temperature.
  

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Use as directed by your doctor or pharmacist

INGREDIENTS AND APPEARANCE

TEARS RENEWED LUBRICANT 
dextran 70 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-0039(NDC: 17478-061)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.001 mL  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	0.003 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-0039-1	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	Business Operations
Preferred Pharmaceuticals, Inc		791119022	relabel