AVITEARS- polysorbate 80 solution/ drops 
Pinnacle Science, LLc

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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Avitears Lubricating Eye Drops

Drug Facts

Active Ingredient

Polysorbate 80, 1%

Purpose

Lubricant

Uses

Warnings

Stop use and ask a doctor

  • If you experience eye pain, changes in vision, continued redness or irritation, or if condition persists for more than 72 hours or worsens
  • Keep this and all other drugs out of the reach of children

Directions

Other Information

Store at 20 to 25° C (68 to 77° F)

Controlled USP Room Temperature

Inactive Ingredients

Citric acid, edetate disodium, WFI water, sodium chloride and the antioxidants: mannitol, pyruvate, retinyl palmitate and sodium citrate.

Principal Display Panel 10mL Bottle Label

AvitearsTM

Lubrication Eye Drops

0.33 FL.OZ

(10mL)

Maximum Strength for Dry Eyes

Principal Display Panel 10mL Bottle Label

Principal Display Panel 10mL Carton Label

Sterile

AvitearsTM

Lubrication Eye Drops

.33 FL.OZ

(10mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Principal Display Panel 10mL Carton Label

Principal Display Panel 15mL Bottle Label

AvitearsTM

Lubrication Eye Drops

0.5 FL.OZ

(15mL)

Maximum Strength for Dry Eyes

Principal Display Panel 15mL Bottle Label

Principal Display Panel 15mL Carton Label

Sterile

AvitearsTM

Lubrication Eye Drops

.5 FL.OZ

(15mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Principal Display Panel 15mL Carton Label
AVITEARS 
polysorbate 80 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49869-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H) polysorbate 8010 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium citrate (UNII: 1Q73Q2JULR)  
sodium chloride (UNII: 451W47IQ8X)  
citric acid monohydrate (UNII: 2968PHW8QP)  
mannitol (UNII: 3OWL53L36A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49869-002-0210 mL in 1 BOTTLE, PLASTIC
2NDC:49869-002-0115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/17/2009
Labeler - Pinnacle Science, LLc (828202494)

Revised: 8/2009
Document Id: a238b922-010a-40fb-8ee8-da3a82c376c4
Set id: dbb0d312-c79a-4c89-acb1-b895b52c05d5
Version: 1
Effective Time: 20090831
 
Pinnacle Science, LLc