Avitears
FDA Label NDC 49869-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pinnacle Science, Llc for the product Avitears (NDC 49869-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 Bottle Label (Avitears 01)

Principal Display Panel 10ml Bottle Label (Avitears 01)

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 (Avitears 02)

Principal Display Panel 10ml Carton Label (Avitears 02)

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 (Avitears 03)

Principal Display Panel 15ml Bottle Label (Avitears 03)

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 04)

Principal Display Panel 15ml Carton Label (Avitears 04)

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