Drug Labeling and Warnings

Drug Details [pdf]

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.

MAJOR LUBRIFRESH PM 
mineral oil and white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6987(NDC: 0904-6488)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	830 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6987-3	1 in 1 CARTON	07/05/2017	10/25/2019
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/05/2017	10/25/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-6987)

Revised: 10/2019

Document Id: d55d7c04-92d8-4311-ba37-c383a78ca201

34390-5

Set id: f52d12ef-b3c8-4d85-9db7-aed9cb496b46

Version: 2

Effective Time: 20191025