Label: LUBRICANT PM- mineral oil, white petrolatum lubricant eye ointment ointment

  • NDC Code(s): 71406-124-35
  • Packager: AACE PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • SPL UNCLASSIFIED SECTION

    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.

  • ACTIVE INGREDIENTS

    Mineral Oil 42.5% and White Petrolatum 57.3%

  • PURPOSE

    Lubricant

  • USES

    • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind and sun.

    • May be used as a protectant against further irritation.
  • WARNINGS

    • For external use only.

    • To avoid contamination, do not touch the tip of container to any surface. Replace cap after using.
  • Stop use and ask a doctor if

    • you feel eye pain.

    • changes in vision occur.

    • redness or irritation of the eye(s) gets worse, persists or lasts 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 and apply a small amount (one fourth inch) of ointment to the inside of the eyelid.
  • OTHER INFORMATION

    • Store away from heat.

    • Protect from freezing.

    • Use only if tape seals on top and bottom flaps are intact.

    • Use before expiration date marked on container.

    • Store at 15° to 30°C (59° to 86°F).

    RETAIN THIS CARTON FOR FUTURE REFERENCE.

  • INACTIVE INGREDIENTS

    Lanolin Alcohols.

  • PRINCIPAL DISPLAY PANEL


    NDC#: 71406-124-35

    Compare to Refresh P.M. ® Ointment active ingredients*

    Lubricant PM Ointment

    Sensitive

    Preservative Free

    Ointment for Nighttime Dry Eye Relief

    Net Wt. 3.5 g (1/8 oz.) Sterile

    Distributed By:

    AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

    www.aacepharma.com


    Rev. 02

    *This product is not manufactured by Allergan, Inc. distributor of Refresh PM ® Ointment.

    NDC 71406-124-35

  • INGREDIENTS AND APPEARANCE
    LUBRICANT PM 
    mineral oil, white petrolatum lubricant eye ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71406-124
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL425 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM573 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71406-124-351 in 1 CARTON03/19/2020
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01803/19/2020
    Labeler - AACE PHARMACEUTICALS, INC. (080630748)
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