Floril Tears
FDA Label NDC 16995-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitaline S.a.c. for the product Floril Tears (NDC 16995-002). 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 floril tears, otc - active ingredient, when using this product, stop use and ask a doctor if, keep our of reach of children., inactive ingredients, warnings, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Floril Tears

Carton Of Floril Tear (Caja Floril T)

Carton Of Floril Tear (Caja Floril T)

Otc - Active Ingredient

Active ingredients     Purpose


Polyvinyl Alcohol  1,4%   Lubricant

Polyethylene Glycol 400 0,2% Lubricant

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, 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.

* Please review the disclaimer below.