Label: ALTALUBE- mineral oil and petrolatum ointment

  • NDC Code(s): 59390-198-50
  • Packager: Altaire Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • SPL UNCLASSIFIED SECTION

    ActivEyes

    Altalube Ointment 3.5g

    NDC 59390-198-50

    Drug Facts

  • Active ingredients

    Mineral Oil 15% and White Petrolatum 85%

  • Purpose

    Eye Lubricant

  • Uses

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

  • Warnings

    • Save box for complete information. • For use in the eyes only.

    When using this product

    • avoid contamination, do not touch tip of container to any surface.

    • replace cap after each use.

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye. • condition worsens or persists for more than 72 hours.

    Keep this and all drugs 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 and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid every 3-4 hours or as directed by a doctor.

  • Other information

    • store at room temperature 15°-30°C (59°-86°F). • protect from freezing.

    • see crimp of tube or box for lot number and expiration date.

    • keep tightly closed.

    • does not contain preservatives.

  • Inactive Ingredients

    None remove

  • Questions or comments?

    • (631) 722-5988• 9AM – 5 PM EST Monday- Friday

  • PRINCIPAL DISPLAY PANEL

    ActiEyes Altalube OintmentWhite Petrolatum and Mineral OilLubricant Eye Ointment Preservative FreeSterileNET WT3.5g (1/8 OZ)







    ActiEyes Altalube Ointment White Petrolatum and Mineral Oil Lubricant Eye Ointment Preservative Free Sterile NET WT 3.5g (1/8 OZ)

  • INGREDIENTS AND APPEARANCE
    ALTALUBE 
    mineral oil and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-198
    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) PETROLATUM850 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-198-501 in 1 CARTON02/01/2002
    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 DrugM01802/01/2002
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceuticals, Inc.786790378manufacture(59390-198)
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