Nuvagel by PureTek Corporation NUVAGEL-

Nuvagel by

Drug Labeling and Warnings

Nuvagel by is a Other medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Rx Only

For external use only

Description

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

Nuvagel™ 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.

Use under the direction of a medical practitioner.

Contraindications:

Nuvagel™ 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.
2) Do not apply to the surgical wound until at least 1 week after suture removal.
3) 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).
4) Product can be reused. If adhesive side is dirty, rinse with warm water and allow
to be dried before reapplying .
5) The NuvagelTM Silicone Gel Scar Dressing should not be shared with other
individuals.
6) Do not use on unhealed or open wounds.

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

Storage time above these conditions should not exceed 18 hours.

Dosage & Administration:

Important:
Apply the Nuvagel™ 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 Nuvagel™ 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 Nuvagel™ 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:

Nuvagel™ is provided in a shipping pouch containing three (3) individually wrapped pouches.  Each pouch contains one Nuvagel™ 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 Nuvagel™ may cause skin irritations including redness, stinging or other irritations. Those effects should go away after use of Nuvagel™ is discontinued.

Manufacturer:

Nuvagel™ is manufactured by:

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:

Nuvagel™

Packaged for :

PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

INGREDIENTS AND APPEARANCE

NUVAGEL 
elastomer, silicone, for scar management

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:59088-781

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:59088-781-50	3 in 1 POUCH
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	MDA	04/09/2021

Labeler - PureTek Corporation (785961046)