Label: LUBRICANT EYE- mineral oil and petrolatum ointment 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Mineral Oil

    12%

    White Petrolatum

    88%

    Contains no preservatives or lanolin.

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  • Purpose

    Eye lubricant

    Eye lubricant

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  • Uses

    For use as a lubricant for the temporary relief of burning and irritation due to dryness of the eyes.

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  • Warnings

    • Do not use if bottom ridge of tube is exposed.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

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  • Other information

    • Store at 20° to 25°C (68° to 77°F)
      [see USP Controlled Room Temperature].
    • Store away from heat.
    • Protect from freezing.
    • Keep tightly closed.
    • See crimp for Control Number and Expiration Date.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.

    NJTROAC Rev. 06/12

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-063-35 Akorn Logo

    Lubricant Eye OINTMENT

    Nighttime Relief For Dry Eyes Sterile

    FOR OPHTHALMIC USE ONLY Net Wt. 3.5 g (1/8oz.)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-063-35

    3.5 g

    Lubricant

    Eye

    OINTMENT

    Nighttime Relief

    For Dry Eyes

    Nighttime Relief

    Plus Protection

    Sterile

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

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE 
    mineral oil and petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17478-063
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Mineral Oil (Mineral Oil) Mineral Oil 120 mg  in 1 g
    Petrolatum (Petrolatum) Petrolatum 880 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-063-35 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 04/01/1993
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(17478-063), ANALYSIS(17478-063), STERILIZE(17478-063), PACK(17478-063), LABEL(17478-063)
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