Revital Eyes
FDA Label NDC 73197-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lunovus, Llc for the product Revital Eyes (NDC 73197-001). 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 other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by
Lunovus, LLC
729 1st Ave N,
Birmingham AL 35203

Otc - Purpose

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only.

Do Not Use

  • if solution 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, persists or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before using.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Store at room temperature.

Inactive Ingredients

Aminomethylpropanol, boric acid, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

1-800-980-6551

Principal Display Panel - 15 Ml Bottle Carton

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RevitalEyes
Refreshing Eye Drops

Ultra-High Performance Lubricant Eye Drops

  • ✓Preservative
    Free
  • ✓Sterile
  • ✓Moisturizing
  • ✓Relieving
  • ✓Soothing
  • Compares to Systane® Ultra Active Ingredients‡
    3 x 0.5 FL OZ (15ml)

    Principal Display Panel (15 ml Bottle Carton)

    Principal Display Panel (15 ml Bottle Carton)

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