Label: PURALUBE- mineral oil and petrolatum ointment

  • NDC Code(s): 48102-017-11, 48102-017-20, 48102-017-35
  • Packager: Fera Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

If you are a consumer or patient please visit this version.

  • Active ingredients

    Mineral Oil (150mg) 15% and White Petrolatum (850mg) 85%

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  • Purpose

    Eye Lubricant

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  • Uses

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

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

    When using this product

    • 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,
    • 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.

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  • 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.
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  • Other information

    • store at 20º - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature].
    • protect from freezing.
    • see crimp of tube or box for lot number and expiration date.
    • keep tightly closed.
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  • Questions and comments?

    • (414) 434-6604
    • 9 AM - 5 PM EST Monday - Friday
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  • PURALUBE® OINTMENT

    PETROLATUM OPHTHALMIC OINTMENT
    STERILE OCULAR LUBRICANT

    DESCRIPTION: A sterile ocular emollient (lubricant).

    Contains: Mineral Oil 15% and White Petrolatum 85%.

    INDICATIONS: For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

    DIRECTIONS: Pull down the lower eyelid of the affected eye(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

    WARNINGS: To avoid contamination of this product do not touch the tip of the container to any surface. Replace cap after using. 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, discontinue use and consult a doctor.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

    DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

    FOR USE IN THE EYES ONLY

    See crimp tube or box for lot number and expiration date.

    STORAGE: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

    KEEP TIGHLTY CLOSED

    HOW SUPPLIED:

    1/8 oz (3.5g) Tube NDC 48102-017-35

    Carton of Twenty (20) Unit Dose 1g Tube NDC 48102-017-20

    Manufacture For: FERA
    Fera Pharmaceuticals, LLC
    Locust Valley, NY 11560

    PF017A
    Rev. 02/11

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  • Principal Display Panel - Carton Label
  • Principal Display Panel - Tube Label

    3.5 gram tube label

    NDC 48102-017-35

    FERA

    Puralube® Ointment

    PETROLATUM OPHTHALMIC OINTMENT

    STERILE OCULAR LUBRICANT

    NET WT 3.5 g (1/8 Oz)

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  • INGREDIENTS AND APPEARANCE
    PURALUBE 
    mineral oil and white petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:48102-017
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 150 mg  in 1 g
    PETROLATUM (PETROLATUM) PETROLATUM 850 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48102-017-35 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    2 NDC:48102-017-20 20 in 1 CARTON
    2 NDC:48102-017-11 1 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 02/02/2011
    Labeler - Fera Pharmaceuticals (831023713)
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