Label: LUBRIFRESH P.M.- white petrolatum mineral oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 24, 2012

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  • 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

    Lubrifresh P.M.

  • INGREDIENTS AND APPEARANCE
    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
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