LUBRIFRESH P.M.- white petrolatum mineral oil ointment 
Rebel Distributors Corp

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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Artificial Tears Ointment Drug Facts

Active ingredient

Mineral oil 15%
White petrolatum 83%

Purpose

Lubricant

Uses

Warnings

When using this product  

Stop use and ask a doctor if

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

 

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

Lubrifresh P.M.

LUBRIFRESH P.M. 
white petrolatum mineral oil ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-342(NDC:0904-5168)
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 (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-342-353.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/09/2011
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 1/2012
Document Id: e475d997-09f2-46b7-9750-6f7c8f032f2b
Set id: e475d997-09f2-46b7-9750-6f7c8f032f2b
Version: 1
Effective Time: 20120124
 
Rebel Distributors Corp