TEARS RENEWED LUBRICANT - dextran 70 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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Drug Facts

Active Ingredients

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

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

Uses

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

Stop use and ask a doctor if

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

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

image of Tears Renewed label

Use as directed by your doctor or pharmacist

TEARS RENEWED LUBRICANT 
dextran 70 solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0039(NDC:17478-061)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.001 mL  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES0.003 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-0039-115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/16/2010
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022relabel

Revised: 5/2011
Document Id: e19a5fd5-1a79-46ab-abf7-72315637b4b8
Set id: 8cb4d4b4-44e5-4584-a4a4-940ad50b2f9d
Version: 7
Effective Time: 20110506
 
Preferred Pharmaceuticals, Inc