LUBRIFRESH P.M. (WHITE PETROLATUM MINERAL OIL) OINTMENT [REBEL DISTRIBUTORS CORP]

LUBRIFRESH P.M. (WHITE PETROLATUM MINERAL OIL) OINTMENT [REBEL DISTRIBUTORS CORP]
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NDC 21695-342-35
Set ID e475d997-09f2-46b7-9750-6f7c8f032f2b
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART349
  • 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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