LUBRIFRESH P.M.- white petrolatum mineral oil ointment

LubriFresh P.M. by

Drug Labeling and Warnings

LubriFresh P.M. by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral oil 15%
White petrolatum 83%

Purpose

Lubricant

Uses

• to prevent further irritation
• to relieve dryness of the eye

Warnings

When using this product  

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

Stop use and ask a doctor if

• condition worsens or persists for more than 72 hours
• you experience eye pain, changes in vision, continued redness or irritation of the eye

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)
•   apply a small amount (1/4 inch) of ointment to the inside of eyelid
•   apply one or more times daily or as directed by a doctor

Other information

• store at 15° - 30°C (59° - 86°F)
• keep tightly closed
• see crimp of tube or carton for Lot Number and Expiration Date

 

Inactive ingredient

lanolin oil

Questions or comments?

Serious side effects associated with use of this product may be reported to 1800-323-0000

*Major LubriFreshTM P.M. is not manufactured or distributed by Allergan Inc., distributor of Refresh P.M.®

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LUBRIFRESH P.M. 
white petrolatum mineral oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-342(NDC: 0904-5168)
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 (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-342-35	3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/09/2011

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK