Refresh Classic Solution/ Drops
FDA Label NDC 0023-0506

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allergan, Inc. for the product Refresh Classic (NDC 0023-0506). 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, active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Polyvinyl Alcohol 1.4%

Povidone 0.6%

Purpose

Eye lubricant

Eye lubricant

Uses

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

Warnings

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.
  • If solution changes color or becomes cloudy, do not use.

Otc - Stop Use

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for 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

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other Information

  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59°-86°F (15°-30°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

1.800.433.8871

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Package Label.Principal Display Panel

NDC 0023-0506-01

Preservative-free

Refresh®
Classic
Lubricant Eye Drops

Moisture drops
for dry eyes

30 Single-Use Containers
0.01 fl oz (0.4 mL) each Sterile

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