Label: ARTIFICIAL TEARS- mineral oil and petrolatum ointment

  • 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 February 8, 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 eyes.

  • 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 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.
  • Inactive ingredient

    Lanolin 2%

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 13985-600-03

    Apexa logo

    Artificial Tears STERILE

    Ophthalmic Lubricant Ointment

    Prevents Irritation and Relieves Dryness of the eye

    Can be used at bedtime

    AP 704001 Net Weight: 3.5g (1/8 oz)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 13985-600-03

    Artificial Tears

    Ophthalmic

    Lubricant

    Ointment

    STERILE

    Prevents Irritation

    and Relieves

    Dryness of the eye

    Can be used

    at bedtime

    Apexa logo

    AP 704001

    Net Weight: 3.5g (1/8 oz)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    mineral oil and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13985-600
    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:13985-600-031 in 1 CARTON03/23/2015
    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 finalpart34903/23/2015
    Labeler - MWI (019926120)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(13985-600) , ANALYSIS(13985-600) , STERILIZE(13985-600) , PACK(13985-600) , LABEL(13985-600)
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