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Skarcade
  • Professionals
  • FDA PI

Skarcade

Dosage form: gel pad

INDICATIONS
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
  • Rash,
  • Skin Discoloration
  • Pruritus,
  • Sheeting tack and thickness vary

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

Discoloration of the skin covered by 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 gel sheeting surface tack and thickness from sheet to sheet. Perception of tack is subjective and the adhesive characteristic of 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 silicone gel sheeting. These products will create a barrier between the scar site and silicone gel, preventing a proper healing environment.

For children under 5 years of age, use under adult supervision.

INSTRUCTIONS FOR USE
Silicone Gel Sheeting

  1. Wash both scar and hands per clean