Active Ingredients
Polyethylene glycol 400 0.4%
Propylene glycol 0.3%
Avenova Lubricant Eye Drops High Performance Solution/ Drops
FDA Label NDC 81963-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Novabay Pharmaceuticals, Inc. for the product Avenova Lubricant Eye Drops High Performance (NDC 81963-101). 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 ingredients, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Lubricant
Lubricant
Use
- for the temporary relief of burning and irritation due to dryness of the eye
Warnings
For external use only
Do Not Use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
When Using This Product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
Stop Use And Ask A Doctor If
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye(s) gets worse or lasts more than 72 hours
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
instill 1 to 2 drops in the affected eye(s) as needed
Other Information
store at 15°-30°C (59°-86°F)
Inactive Ingredients
aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol
Questions Or Comments?
Call 1-800-890-0329
Email: [email protected]
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