Nuvazil: Package Insert and Label Information

NUVAZIL-
Hudson Scientific LLC

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:

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Nuvazil™ Box

The front of the Nuvazil™ box is pictured below:

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The back of the Nuvazil™ box is pictured below:

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NUVAZIL
Product Information
Product Type Item Code (Source) NHRIC:70914-020
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:70914-020-01 15 POUCH in 1 BOX contains a POUCH
1 1 in 1 POUCH This package is contained within the BOX (70914-020-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device MDA 03/01/2017
Labeler — Hudson Scientific LLC (080339637)
Establishment
Name Address ID/FEI Operations
Hudson Scientific LLC 080339637 repack

Revised: 11/2019 Hudson Scientific LLC

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