Lubricant Eye
FDA Label NDC 17478-063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akorn for the product Lubricant Eye (NDC 17478-063). 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 ingredient, 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 Ingredient

Mineral Oil

12%

White Petrolatum

88%

Contains no preservatives or lanolin.

Purpose

Eye lubricant

Eye lubricant

Uses

For use as a lubricant for the temporary relief of burning and irritation due to dryness of the eyes.

Warnings

  • Do not use if bottom ridge of tube is exposed.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

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

Directions

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

Other Information

  • Store at 20° to 25°C (68° to 77°F)
    [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

    • NJTROAC Rev. 06/12

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 17478-063-35 Akorn Logo

Lubricant Eye OINTMENT

Nighttime Relief For Dry Eyes Sterile

FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-063-35

3.5 g

Lubricant

Eye

OINTMENT

Nighttime Relief

For Dry Eyes

Nighttime Relief

Plus Protection

Sterile

Net Wt. 3.5 g (1/8oz.)

* Please review the disclaimer below.