Avitears Lubricating Eye Drops

SPL v1

SPL

SPL Set ID dbb0d312-c79a-4c89-acb1-b895b52c05d5

Route

TOPICAL

Published

Effective Date 2009-08-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polysorbate 80 (10 mg)

Inactive Ingredients

Sodium Citrate Sodium Chloride Citric Acid Monohydrate Mannitol Edetate Disodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-07-17

Description

Polysorbate 80, 1%

Purpose

Lubricant

Medication Information

Purpose

Lubricant

Description

Polysorbate 80, 1%

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

Directions

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

Active Ingredient

Polysorbate 80, 1%

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.

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

Principal Display Panel 10ml Bottle Label

Avitears^TM

Lubrication Eye Drops

0.33 FL.OZ

(10mL)

Maximum Strength for Dry Eyes

Principal Display Panel 10ml Carton Label

Sterile

Avitears^TM

Lubrication Eye Drops

.33 FL.OZ

(10mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Principal Display Panel 15ml Bottle Label

Avitears^TM

Lubrication Eye Drops

0.5 FL.OZ

(15mL)

Maximum Strength for Dry Eyes

Principal Display Panel 15ml Carton Label

Sterile

Avitears^TM

Lubrication Eye Drops

.5 FL.OZ

(15mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Structured Label Content

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

Purpose

Lubricant

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

Directions

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

Active Ingredient

Polysorbate 80, 1%

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.

Stop Use and Ask A Doctor (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

Principal Display Panel 10ml Bottle Label (Principal Display Panel 10mL Bottle Label)

Avitears^TM

Lubrication Eye Drops

0.33 FL.OZ

(10mL)

Maximum Strength for Dry Eyes

Principal Display Panel 10ml Carton Label (Principal Display Panel 10mL Carton Label)

Sterile

Avitears^TM

Lubrication Eye Drops

.33 FL.OZ

(10mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Principal Display Panel 15ml Bottle Label (Principal Display Panel 15mL Bottle Label)

Avitears^TM

Lubrication Eye Drops

0.5 FL.OZ

(15mL)

Maximum Strength for Dry Eyes

Principal Display Panel 15ml Carton Label (Principal Display Panel 15mL Carton Label)

Sterile

Avitears^TM

Lubrication Eye Drops

.5 FL.OZ

(15mL)

No Preservatives

Antioxidant Based

Maximum Strength for Dry Eyes

Advanced Ingredient Data

[{"name": "polysorbate 80", "unii": "6OZP39ZG8H", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "sodium citrate", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium chloride", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "citric acid monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "mannitol", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Lubricant", "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", "Directions": "Instill one or two drops in the affected eye(s) as needed", "Active Ingredient": "Polysorbate 80, 1%", "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.", "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", "Principal Display Panel 10mL Bottle Label": "Avitears TM Lubrication Eye Drops 0.33 FL.OZ (10mL) Maximum Strength for Dry Eyes", "Principal Display Panel 10mL Carton Label": "Sterile Avitears TM Lubrication Eye Drops .33 FL.OZ (10mL) No Preservatives Antioxidant Based Maximum Strength for Dry Eyes", "Principal Display Panel 15mL Bottle Label": "Avitears TM Lubrication Eye Drops 0.5 FL.OZ (15mL) Maximum Strength for Dry Eyes", "Principal Display Panel 15mL Carton Label": "Sterile Avitears TM Lubrication Eye Drops .5 FL.OZ (15mL) No Preservatives Antioxidant Based Maximum Strength for Dry Eyes"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:57.928719 · Updated: 2026-03-14T22:52:12.899376