Otc - Active Ingredient
Active ingredients Purpose
Polyvinyl Alcohol 1,4% Lubricant
Floril Tears
FDA Label NDC 16995-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vitaline S.a.c. for the product Floril Tears (NDC 16995-004). 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 otc - active ingredient, when using this product, stop use and ask a doctor if, keep our of reach of children., inactive ingredients, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
When Using This Product
- do not touch the tip of the container to any surface to avoid contamination
- replace cap after each use
- remove contact lenses before using
Stop Use And Ask A Doctor If
- You feel eye pain
- changes in vision occur
- condition worsens or lasts more than 72 hours
Keep Our Of Reach Of Children.
If swallowed get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Benzalkonium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polysorbate 80, sodium chloride, polyethylene glycol 300, purified water.
Warnings
For external use only.
Do not use if the solution changes color or become cloudy.
Directions
- Put 1 to 2 drops in the affected eyes up to times daily.
Other Information
Enter section text here
Uses
- temporary relief of eye dryness and redness due to insufficient production of tears.
- prevents further irritation.
Package Label.Principal Display Panel
Floril Tears Box (Caja Floril T)
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