FDA Label for Floril Redness Relief

View Indications, Usage & Precautions

Floril Redness Relief Product Label

The following document was submitted to the FDA by the labeler of this product Vitaline S.a.c.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel




Actives Ingredients Purpose



Naphazoline Hydrocloride 0,03% redness reliever
Polysorbate 20 0,24% Lubricant


Inactive Ingredients



Benzalkonium chloride, chamomile, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, purified water.


Warnings



For external use only

Ask a doctor before use if you have narrow angle glaucoma

Do not use if the solution changes color or becomes cloudy


Otc - When Using



  • do not touch the tip of the container to any surface to avoid contamination
  • replace cap after each use
  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
  • remove contact lenses before using

Stop Use And Ask Doctor If



  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children



If swallowed get medical help or contact a Poison Control Center right away


Use



Relieves redness of the eye due to minor eye irritations


Directions



Put 1 to 2 drops in the affected eye(s) up to 4 times daily.


Other Information



Store at room temperature 15° to 30° (59° to 86° F).


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