Floril Redness Relief
FDA Label NDC 16995-001

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 Redness Relief (NDC 16995-001). 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 package label.principal display panel, actives ingredients purpose, inactive ingredients, warnings, otc - when using, stop use and ask doctor if, otc - keep out of reach of children, use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

Box Floril Redness Relief (Cajaflorilr)

Box Floril Redness Relief (Cajaflorilr)

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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