LUBRICANT EYE (MINERAL OIL AND PETROLATUM) OINTMENT [AKORN, INC.]

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LUBRICANT EYE (MINERAL OIL AND PETROLATUM) OINTMENT [AKORN, INC.]
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NDC 17478-063-35
Set ID b086dc94-ff35-43c6-a5a0-8a25d6104d61
Category HUMAN OTC DRUG LABEL
Packager Akorn, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Mineral Oil

    12%

    White Petrolatum

    88%

    Contains no preservatives or lanolin.

  • Purpose

    Eye lubricant

    Eye lubricant

  • Uses

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

  • 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.

  • 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.

  • 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

  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE 
    mineral oil and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-063
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil120 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum880 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-063-351 in 1 CARTON04/01/1993
    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 finalpart34904/01/1993
    Labeler - Akorn, Inc. (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696840MANUFACTURE(17478-063) , ANALYSIS(17478-063) , STERILIZE(17478-063) , PACK(17478-063) , LABEL(17478-063)
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