Nuvazil II

Manufacturer
PureTek Corporation
Effective date
2021-02-08
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:53

Label at a glance#

ProductNuvazil II
Label structure12 sections

Indications and uses

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

Storage and handling

Keep out of direct sunlight and under 40°C (104°F). Storage time above these conditions should not exceed 18 hours.

Label contents#

Full prescribing information#

Rx Only

SPL UNCLASSIFIED SECTION

For external use only

Description

DESCRIPTION SECTION

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

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

Indications and Usage

INDICATIONS & USAGE SECTION

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

Contraindications:

CONTRAINDICATIONS SECTION

Nuvazil™II is contraindicated for patients with sensitivity to silicone.

Warnings and Precautions:

WARNINGS AND PRECAUTIONS SECTION

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™II 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°C (104 °F).


Storage time above these conditions should not exceed 18 hours.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

Important:
Apply the Nuvazil™II 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™II 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™II 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:

HOW SUPPLIED SECTION

Nuvazil™II is provided in a shipping pouch containing four (4) individually wrapped pouches.  Each pouch contains one Nuvazil™II 10 cm x 12 cm pad.

Storage and Handling:

STORAGE AND HANDLING SECTION

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

Storage time above these conditions should not exceed 18 hours.

Adverse Reactions:

ADVERSE REACTIONS SECTION

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

Manufacturer:

SPL UNCLASSIFIED SECTION

Nuvazil™II is manufactured by:

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

Rx Only

Nuvazil™II Pouch Label

SPL UNCLASSIFIED SECTION

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

image descriptionimage description

Nuvazil™II Shipping Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-768-90Nuvazil II1 in 1 POUCH12
59088-768-90Nuvazil II4 in 1 POUCH42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-768NUVAZIL II () [PURETEK CORPORATION]22 package rows20210209_fcec585c-7f57-4e2e-8239-8bda5a8648c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-768-90EA - Each59088-7687d99a7bd-ada5-42a5-aaa4-7435d4b37e7e12021-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-76859088-768-90

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.