Refresh P.m. Ointment
FDA Label NDC 0023-0240

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 P.m. (NDC 0023-0240). 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

Mineral Oil 42.5%

White Petrolatum 57.3%

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.
  • 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 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 and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

  • Store away from heat.
  • Protect from freezing.
  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
  • Use before expiration date marked on container.
  • Store at 59°-86°F (15°-30°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive Ingredients

Lanolin alcohols

Questions Or Comments?

1.800.433.8871

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NDC 0023-0240-04

Preservative-free

Refresh

P.M.®
Lubricant Eye
Ointment

NIGHTTIME OINTMENT

Protects the eyes
from nighttime
dryness and exposure

Net wt. 0.12 oz (3.5 g) Sterile

* Please review the disclaimer below.