MAJOR LUBRIFRESH PM- mineral oil and white petrolatum ointment 
Preferred Pharmaceuticals Inc.

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.

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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

Repackaged By: Preferred Pharmaceuticals Inc.

LubriFresh P.M. Lubricant Eye Ointment
MAJOR LUBRIFRESH PM 
mineral oil and white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6987(NDC:0904-6488)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-6987-31 in 1 CARTON07/05/201710/25/2019
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/05/201710/25/2019
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6987)

Revised: 10/2019
Document Id: d55d7c04-92d8-4311-ba37-c383a78ca201
Set id: f52d12ef-b3c8-4d85-9db7-aed9cb496b46
Version: 2
Effective Time: 20191025
 
Preferred Pharmaceuticals Inc.