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Major LubriFresh PM by Major Pharmaceuticals

Dosage form: ointment
Ingredients: MINERAL OIL 150mg in 1g, PETROLATUM 830mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-6488

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients                                               Purpose

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

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

When using this product

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

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

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) and apply a small amount (1/4") of ointment to the inside of eyelid

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 ingredients

lanolin alcohol

Distributed by:

Major Pharmaceuticals

17177 N Laurel Park Dr.,

Suiet 233

Livonia, MI 48150

Made in Korea

MAJOR LUBRIFRESH PM 
mineral oil and white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6488
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL150 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN ALCOHOLS 
Packaging
#Item CodePackage Description
1NDC:0904-6488-381 TUBE in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/11/2015
Labeler - Major Pharmaceuticals (191427277)

Revised: 02/2017
 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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