AVITEARS- polysorbate 80 solution/ drops

Avitears by

Drug Labeling and Warnings

Avitears by is a Otc medication manufactured, distributed, or labeled by Pinnacle Science, LLc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Polysorbate 80, 1%

Purpose

Lubricant

Uses

• Temporary relief of discomfort, burning and irritation due to dryness of the eye or from exposure to wind, sun, computer use, environmental conditions, prescription medication, post-surgical dry eye or systemically induced dry eye.
• Lubricant and protectant from further irritation

Warnings

• For external use only
• To avoid contamination replace cap after use
• Do not touch the tip of the container to any surface to avoid contamination
• Do not use if solution changes color or becomes cloudy

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

• Instill one or two drops in the affected eye(s) as needed

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 Carton Label

Sterile

AvitearsTM

Lubrication Eye Drops

.33 FL.OZ

(10mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Principal Display Panel 15mL Bottle Label

AvitearsTM

Lubrication Eye Drops

0.5 FL.OZ

(15mL)

Maximum Strength for Dry Eyes

Principal Display Panel 15mL Carton Label

Sterile

AvitearsTM

Lubrication Eye Drops

.5 FL.OZ

(15mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

INGREDIENTS AND APPEARANCE

AVITEARS 
polysorbate 80 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49869-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H)	polysorbate 80	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
sodium citrate (UNII: 1Q73Q2JULR)
sodium chloride (UNII: 451W47IQ8X)
citric acid monohydrate (UNII: 2968PHW8QP)
mannitol (UNII: 3OWL53L36A)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49869-002-02	10 mL in 1 BOTTLE, PLASTIC
2	NDC: 49869-002-01	15 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/17/2009

Labeler - Pinnacle Science, LLc (828202494)