Label: PENLEN SPRAY EMULSION-

  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated December 4, 2018

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

  • DESCRIPTION

    Penlen® Spray Emulsion is a water-based topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis.

    Penlen® Spray Emulsion contains natural extracts to moisturize the skin.

  • INDICATIONS & USAGE

    As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis.

    Penlen® Spray Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

  • CONTRAINDICATIONS

    Penlen Spray Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation

  • PRECAUTIONS

    Penlen® Spray Emulsion is for external use only.

    Product should not be used prior to MRI Imaging, as it contains silver nanoparticles that can cause heating during these procedures.

    Penlen® Spray Emulsion does not contain sunscreen.

    If the condition does not improve within 10 days, consult a physician.

    If clinical signs of infection are present, appropriate treatment should be initiated; use of Penlen® Spray Emulsion may be continued during anti-infective therapy.

    Keep this and other similar products out of the reach of children.

  • DIRECTIONS FOR USE

    Spray a small amount of Penlen® Spray Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

  • INGREDIENTS

    De-ionized water, copolymer, sodium hyaluronate in vegetable oils from African palms and silver nanoparticles (as a preservative).

  • HOW SUPPLIED

    Penlen® Spray Emulsion is available in a 90 mL spray bottle.

    PRESCRIPTION MEDICAL DEVICE: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

  • STORAGE AND HANDLING

    STORE AT ROOM TEMPERATURE

    SHAKE WELL BEFORE USING

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S.A. by:

    SI Pharmaceuticals LLC
    Madison, MS 39110

    Manufactured by: Laboratorios Zepol S.A. Costa Rica

    FDA approval: K141637

  • Container Label

    Penlen® Spray Emulsion 90 mL

    Penlen® Spray Emulsion 90 mL (NDC 70063-100-01)
    For Topical Dermatological Use only.
    Rx Only

  • INGREDIENTS AND APPEARANCE
    PENLEN SPRAY EMULSION 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:70063-100
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70063-100-011 in 1 CARTON
    190 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK14163712/04/2018
    Labeler - SI Pharmaceuticals LLC (079881205)