Label: ARTIFICIAL TEARS- mineral oil and white petrolatum ointment

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Mineral Oil 15%

    White Petrolatum 83%

  • Purpose

    Eye lubricant

    Eye lubricant

  • Uses

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

  • Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.

    Stop use and ask a doctor if condition persists or increases discontinue use and consult veterinarian.

    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.
  • Inactive ingredient

    Lanolin 2%

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 59399-162-35 Akorn Animal Health Logo

    3.5 g

    ARTIFICIAL TEARS

    Lubricant Ophthalmic Ointment FOR OPHTHALMIC USE ONLY

    For Veterinary Use Net Wt 3.5g (1/8 oz) Sterile

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 59399-162-35

    Akorn Animal Health Logo

    3.5 g

    ARTIFICIAL

    TEARS

    Lubricant Ophthalmic

    Ointment

    For

    Veterinary

    Use

    Sterile

    Net Wt 3.5g (1/8 oz)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    mineral oil and white petrolatum ointment
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59399-162
    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:59399-162-351 in 1 CARTON
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/15/2015
    Labeler - Akorn (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Croda Europe Ltd.220690285API MANUFACTURE
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