Lubrifresh P.m.
FDA Label NDC 21695-342

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Lubrifresh P.m. (NDC 21695-342). 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 active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Mineral oil 15%
White petrolatum 83%

Purpose

Lubricant

Uses

  • to prevent further irritation
  • to relieve dryness of the eye

Warnings

When using this product  

  • replace cap after use
  • do not touch tip of container to any surface to avoid contamination

    • Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • you experience eye pain, changes in vision, continued redness or irritation of the eye

Keep Out Of Reach Of Children.

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

Directions

  •  pull down the lower lid of the affected eye (s)
  •  apply a small amount (1/4 inch) of ointment to the inside of eyelid
  •  apply one or more times daily or as directed by a doctor

Other Information

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • see crimp of tube or carton for Lot Number and Expiration Date

    •  

Inactive Ingredient

lanolin oil

Questions Or Comments?

Serious side effects associated with use of this product may be reported to 1800-323-0000

*Major LubriFreshTM P.M. is not manufactured or distributed by Allergan Inc., distributor of Refresh P.M.®

* Please review the disclaimer below.