Protezall medium silicone gel sheets for scars

Manufacturer
V2 Pharma
Effective date
2023-06-27
Label type
MEDICAL DEVICE
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:50

Label at a glance#

ProductProtezall
Label structure10 sections

Indications and uses

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

Storage and handling

Store at 20-25C (68 to 77F). Keep away from heat and protect from freezing.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

Protezall is a Silicone Gel Scar Dressing which fades and softens existing scars, as well as new hypertrophic keloids or scars.  Protezall is very comfortable to wear, reusable and washable.  Each of the enclosed sheets can last up to eight days with proper care.  

Indications and Usage

INDICATIONS & USAGE SECTION

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

Contraindications:

CONTRAINDICATIONS SECTION

Protezall is contraindicated for patients who are sensitive to silicone.

Warnings and Precautions:

WARNINGS AND PRECAUTIONS SECTION

For external use only.

Stop use in the event of itching, blisters, or skin irritation.

Do not apply to the surgical wound until at least 1 week after sutures, if any, have been removed.  Do not use on open or unhealed wounds.

Clean skin surface before use.  A rash may result if the skin surface has not been cleaned.

Each gel sheet can be reused for up to eight days.  If adhesive side is dirty, wash it gently with a finger using antibacterial soap and water.  Rince gently and allow the sheet to dry.

Protezall should not be shared with others.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

Instructions for use:

  1. Prior to use, wash hands and area of application.  Dry thoroughly.
  2. Open the non-sterile pouch containing the Protezall Gel Sheeting
  3. The gel sheet is covered on its "sticky" side by a plastic film.  Remove the gel sheeting from the mylar release strip prior to use.
  4. The gel sheet may be cut into smaller pieces using scissors.  Once you have determined the appropriate size of sheeting to use, apply sticky side to the area.  The gel sheeting should fully cover the area.
  5. Place the sticky side of the gel sheet directly onto the scar.  For best results, wear the gel sheet 8-12 hours per treatment.  Wait 8-12 hours without use before next treatment.
  6. Gel sheet is reusable.  When not wearing the gel sheet, place the gel sheet (sticky side) back onto the mylar release strip.  Place the gel sheet back into the original pouch for protection.
  7. When the sticky side of the gel sheet appears dirty or worn, use your finger to gently wash the gel sheet with anti-bacterial soap and water, as needed.  Rince with water and allow to air dry.  The stickiness will return once dry.  Do not fold while washing or drying.

How Supplied:

HOW SUPPLIED SECTION

Protezall is provided in a box containing four individually wrapped pouches, each containing one Gel Sheet.

Storage and Handling:

STORAGE AND HANDLING SECTION

Store at 20-25C (68 to 77F). Keep away from heat and protect from freezing.

Adverse Reactions:

ADVERSE REACTIONS SECTION

Although very rare, Protezall may cause skin irritations including redness, stinging or other irritations. Those effects should go away after use is discontinued.

Manufacturer:

SPL UNCLASSIFIED SECTION

Protezall is manufactured by Hudson Scientific LLC, Hudson Michigan for:

V2 Pharma LLC
103 W. Main St.
Hudson, MI 49247

Protezall Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Protezall is sold in a box resembling the following:

Protezall BoxProtezall Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72835-100-00Protezall4 in 1 BOX43
72835-100-00Protezall1 in 1 POUCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72835-100PROTEZALL () [V2 PHARMA]32 package rows20230628_28118063-81cf-48a8-b886-848fb349dfb3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72835-100-00EA - Each72835-1006a249268-5f95-4015-bca6-5510cd2c126512023-06-06

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
72835-10072835-100-00

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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