Label: LUBRICANT EYE PM- mineral oil, white petrolatum ointment

  • NDC Code(s): 69618-060-76
  • Packager: Reliable 1 Laboratories LLC
  • 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 August 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Mineral Oil 42.5%

    White Petrolatum 57.3%

  • PURPOSE

    Purpose

    Eye lubricant

  • INDICATIONS & USAGE

    Uses

    • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation.
  • WARNINGS

    Warnings

    For external use only

    When using this product

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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • pull down the lower lid of the affected eye
    • apply a small amount (1/4 inch) of the ointment to the inside of the eyelid
  • STORAGE AND HANDLING

    Other information

    • store at 15°-25°C (59°-77°F)
    • keep tightly closed
    • see crimp of tube or carton for Lot Number and Expiration Date
  • INACTIVE INGREDIENT

    Inactive ingredient

    Lanolin alcohols

  • QUESTIONS

    Questions or comments?

    call 516-341-0666, 8:30 - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Allergan USA, Inc., owner of the registered trademark Refresh P.M.

    Distributed by:

    Reliable-1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF CAP AND NECKRING ARE NOT INTACT

    SAVE CARTON FOR COMPLETE DRUG FACTS

    Lubricant Eye Ointment P.M. provides soothing night time relief for more intense dry, irritated eyes. Ideal for use at bedtime.

    Safe to use as often as needed.

  • PRINCIPAL DISPLAY PANEL

    Compare to Active Ingredients in Refresh P.M.®*

    NDC 69618-060-76

    Reliable-1® LABORATORIES

    LUBRICANT EYE OINTMENT P.M.

    Soothes Irritated, Dry Eyes Overnight

    PRESERVATIVE FREE

    Sterile

    Net Wt. 1/8 OZ (3.5 g)

    Lubricant Eye Ointment PM

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE PM 
    mineral oil, white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-060
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM57.3 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL42.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-060-761 in 1 CARTON01/01/2022
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01801/01/2022
    Labeler - Reliable 1 Laboratories LLC (079718111)
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