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Avitears

Pinnacle Science, LLc

Avitears Lubricating Eye Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Avitears

polysorbate 80 SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49869-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
polysorbate 80 10 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM CITRATE
SODIUM CHLORIDE
CITRIC ACID MONOHYDRATE
mannitol
EDETATE DISODIUM

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2009-07-17


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