Label: ARTIFICIAL TEARS- mineral oil, petrolatum ointment

  • NDC Code(s): 11695-6832-1
  • Packager: Butler Animal Health Supply, LLC dba Covetrus North America
  • Category: OTC ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 8, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 veterinarian 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 veterinarian.

  • 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:

    covetrus logo

    NDC: 11695-6832-1 Reorder #048272

    Artificial tears

    Lubricant ophthalmic ointment For ophthalmic use only

    For veterinary use Net Wt 3.5 g (1/8 oz) Sterile

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    covetrus logo

    NDC: 11695-6832-1

    Artificial

    tears

    Lubricant ophthalmic

    ointment

    For

    veterinary

    use

    Sterile

    Net Wt 3.5 g (1/8 oz)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    mineral oil, petrolatum ointment
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6832
    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:11695-6832-11 in 1 CARTON
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other10/01/2019
    Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Croda Europe Ltd.220690285API MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!