Siladerm Fabric Silicone Gel Sheeting: Package Insert and Label Information

SILADERM FABRIC SILICONE GEL SHEETING-
Primary Pharmaceuticals, Inc.

INDICATIONS

Siladerm Fabric Gel Sheeting is intended for use in the management, control and prevention of old and new hypertrophic or keloid scars resulting from burns or surgical or traumatic injury of the skin.

CONTRAINDICATIONS

Do not use on open wounds or when any Dermatological conditions disrupt the skin (such as a rash).

HOW SUPPLIED

Non-sterile product is labeled as such and supplied in a protective package within a protective outer container.

WARNINGS, PRECAUTIONS, ADVERSE REACTIONS

Possible complications include:

• Superficial maceration of the skin

• Skin Discoloration • Pruritus
• Sheeting tack and thickness vary

Rashes have been observed on skin under the fabric gel sheeting, this has been attributed to poor or insufficient hygiene. Similar rashes have been attributed to fabric gel sheeting being wrapped too tightly. Should a rash occur, stop using the fabric gel sheeting for 12 hours followed by using the fabric gel sheeting for 12 hours. If the rash persists, a physician should be contacted and fabric gel sheeting use should be discontinued.


Discoloration of the skin covered by Fabric Silicone Gel Sheeting has been reported, particularly in dark skinned patients. This effect appears to be transient, and may be similar to the discoloration experienced whenever an area of skin is covered for extended periods of time.


Some patients report differences in Fabric Gel sheeting surface tack and thickness from sheet to sheet. Perception of tack is subjective and the adhesive characteristic of Siladerm Fabric Gel Sheeting may vary. These variations do not affect the function of the product.


Small bubbles may form after repeated washing and use. This does not have an impact on the function of the product. Do not use creams, lotions, sun block or other silicone products on your skin when wearing fabric silicone gel sheeting. These products will create a barrier between the scar site and the fabric silicone gel, preventing a proper healing environment.

INSTRUCTIONS FOR USE

Siladerm Fabric Silicone Gel Sheeting

  1. Wash both scar and hands per cleaning instructions.
  2. Open the non-sterile pouch containing the Siladerm Fabric Silicone Gel Sheet.
  3. The gel sheet is covered on “tacky” side by a plastic film. Remove the fabric gel sheeting from the plastic substrate liner prior to use.
  4. The gel sheet may be cut into smaller pieces using scissors or a scalpel. Once you have determined the appropriate size of sheeting to use, apply tacky side to the scar. The gel sheeting should fully cover the scar and extend ¼ inch all the way around the scar border.
  5. If the product is worn during sleep, it should be secured. Use of medical tape or other means is recommended to keep the product from falling off.

CLEANING INSTRUCTIONS

Remove the fabric gel sheet every 12 hours to wash both the scar and the gel sheet. In a basin of warm water, work up a small amount of lather with soap. Gently wash the piece of gel sheeting in the soapy water, rinse, and then air dry. Make sure the sheeting is completely dry before re-applying to the scar. After washing, rinsing and drying the scar site re-apply the piece of gel sheeting.


WEARING TIME

Optimal wearing time for Siladerm Fabric Silicone Gel Sheeting is 24 hours per day. If it is not possible to wear the gel sheet for the recommended 24 hour period, a minimum of 12 hours per day is required, washing per the instructions above once in that period. Follow this procedure each day, washing and re-applying the gel sheeting to the scar for 1 to 2 weeks. At that time the piece of gel sheeting will begin to lose its adhesive quality and/or may become embedded with surface dirt. When this occurs, discard the piece of gel sheeting and apply a new piece.


The overall optimal period of use is usually 8 to 12 weeks.

Manufactured for:
Primary Pharmaceuticals, Inc.
1019 Government St, Suite E
Ocean Springs, MS 39564

Questions or information: 877.337.0682

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PRINCIPAL DISPLAY PANEL

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SILADERM FABRIC SILICONE GEL SHEETING
Product Information
Product Type Item Code (Source) NHRIC:72275-151
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:72275-151-04 4 POUCH in 1 CARTON contains a POUCH
1 1 in 1 POUCH This package is contained within the CARTON (72275-151-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K003948 10/10/2020
Labeler — Primary Pharmaceuticals, Inc. (066126126)

Revised: 10/2020 Primary Pharmaceuticals, Inc.

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