NUVAZIL () [HUDSON SCIENTIFIC LLC]

NUVAZIL () [HUDSON SCIENTIFIC LLC]
PDF | XML

NDC 70914-020-01
Set ID 1475ea3f-f184-4f01-a75a-71b9672e8fb3
Category MEDICAL DEVICE
Packager Hudson Scientific LLC
Generic Name
Product Class
Product Number
Application Number MDA
  • Rx Only

    For external use only

  • Description

    Nuvazil™ is a Silicone Gel Scar Dressing which is soft, comfortable, self-adhesive and Reusable.

    Nuvazil™ flattens, softens and fades both existing and new hypertrophic scars or keloids.

  • Indications and Usage

    For non-invasive management of both existing and new hypertrophic scars or keloids.

  • Contraindications:

    Nuvazil™ is contraindicated for patients with sensitivity to silicone.

  • Warnings and Precautions:

    For external use only.

    1. Stop use, in case of itching, blisters, or skin irritation.
      Do not apply to the surgical wound until at least 1 week after suture removal.
      Skin surface must be cleaned before use. Using this product on uncleaned skin surface or applying it with excessive tightness may result in roseola (rash).
      Product can be reused. If adhesive side is dirty, rinse with water and allow to be dried before reapplying.
      The Nuvazil™ Silicone Gel Scar Dressing should not be shared with other individuals.
      Do not use on unhealed or open wounds.


    Keep out of direct sunlight and Under 40 0C (104 0F).


    Storage time above these conditions should not exceed 18 hours.

  • Dosage & Administration:

    Important:
    Apply the Nuvazil™ Silicone Gel Scar Dressing to the skin for 4-8 hours to ensure no adverse reactions occur. Once a trial application is completed without adverse reaction, the Nuvazil™ Silicone Gel Scar Dressing may be applied to clean skin nightly before bed and removed each morning. Most treatment period will last for two months. In case of serious skin conditions, continue using for 3-6 months or as directed by your physician.

    How to use:

    1. Open pouch and remove Nuvazil™ Silicone Gel Scar Dressing.
    2. Cut the sheet to the size and shape of the affected skin area. If the skin area is larger, several sheets may be applied with edges aligned.
    3. Remove the plastic film from the back of the sheet carefully and place the adhesive side onto clean skin. With good extensibility, it won’t tend to fall off. However, during sleeping or doing a lot of exercise, you can use a thin flex yarn tape or an adhesive tape to keep it in place.
    4. Replace the sheet weekly or when it is no longer secure on the skin.
  • How Supplied:

    Nuvazil™ is provided in a box containing fifteen (15) individually wrapped pouches.  Each pouch contains one Nuvazil™ 10 cm x 12 cm pad.

  • Storage and Handling:

    Keep out of direct sunlight and under 40°C (104°F).

    Storage time above these conditions should not exceed 18 hours.

  • Adverse Reactions:

    In rare circumstances, use of Nuvazil™ may cause skin irritations including redness, stinging or other irritations. Those effects should go away after use of Nuvazil™ is discontinued.

  • Manufacturer:

    Nuvazil™ is manufactured for:

    Hudson Scientific LLC
    103 W. Main St.
    Hudson, MI 49247

    Rx Only

  • Nuvazil™ Pouch Label​

    The label on each pouch containing a Nuvazil™ sheet is pictured below:

    image description
  • Nuvazil™ Box

    The front of the Nuvazil™ box is pictured below:

    image description

    The back of the Nuvazil™ box is pictured below:

    image description
  • INGREDIENTS AND APPEARANCE
    NUVAZIL 
    elastomer, silicone, for scar management
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:70914-020
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70914-020-0115 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceMDA03/01/2017
    Labeler - Hudson Scientific LLC (080339637)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hudson Scientific LLC080339637repack

Related Drugs