Major Lubrifresh Pm
FDA Label NDC 0904-6488

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Major Lubrifresh Pm (NDC 0904-6488). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                                               Purpose

Mineral oil 15%...................................................Lubricant

White petrolatum 83%.........................................Lubricant

Otc - Purpose

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

Warnings

When using this product

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

Otc - Ask Doctor

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • the condition worsens or persists 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.

Indications & Usage

Directions

  • pull down the lower lid of the affected eye(s) and apply a small amount (1/4") of ointment to the inside of eyelid

Storage And Handling

Other information

  • store away from heat
  • protect from freezing
  • use before expiration date marked on container
  • store at 59°-86°F (15°-30°C)

Inactive Ingredient

Inactive ingredients

lanolin alcohol

Dosage & Administration

Distributed by:

Major Pharmaceuticals

17177 N Laurel Park Dr.,

Suiet 233

Livonia, MI 48150

Made in Korea

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