Label: CELLPAD MEDICAL GRADE SILICONE GEL MATRIX- silicone matrix patch
- NHRIC Code(s): 72678-005-01
- Packager: NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
- Category: MEDICAL DEVICE
Drug Label Information
Updated August 19, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- CellPad Medical Grade Silicone Gel Matrix Description
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CLINICAL PHARMACOLOGY
The exact mechanism of action in improving the appearance of scar tissue from using silicone remains unknown. However, various suggestions have been made to explain the efficacy of silicone sheets, including hydration, pressure, temperature, oxygen transmission and silicone absorption. There is some evidence that the treatment affects the stratum corneum and, by reducing evaporation, restores better homeostasis in the tissue. In keloid and hypertrophic scarring, the stratum corneum allows more evaporation of water from the underlying tissue than occurs in normal skin. Silicone pads may prevent this, keeping the stratum corneum in optimal hydration and protecting the skin from environmental hazards, both of which can reduce abnormal scarring. The gel may also affect the stratum corneum by inhibiting mast cell activity, diminishing edema, vasodilatation and excessive extracellular matrix formation but the simple changes in temperature, pressure, oxygen tension and hydration produced by wound coverage probably constitute the main mechanism of action. Another hypothesis is that the effect of static electricity on silicone may influence the alignment of collagen deposition.
- INDICATIONS AND USES
- CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
Stop use and ask a doctor if irritation develops. In rare instances, silicone sheets may cause a rash on the skin. This condition may result from improper cleansing of the scar area where the silicone pad has been applied. If this product is applied properly and skin irritation still occurs, discontinue use and consult your physician. If ingested, get medical help or contact Poison Control Center right away.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.This medication should be used as directed by your physician during pregnancy or while breastfeeding. Consult your doctor about the risks and benefits.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
- ADVERSE REACTIONS
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DOSAGE AND ADMINISTRATION
- Wash hands and scar area thoroughly with soap and water. Completely dry the area after.
- If needed, cut the CellPad Gel Matrix to size making sure to leave at least 1/4” beyond the area of the scar.
- Peel off the backing of the sheet and place it sticky side down on the affected area.
- For best results, leave on for 8-12 hours per day.
- Each sheet lasts 7 days, box contains 2 weeks supply.
- How is CellPad Medical Grade Silicone Gel Matrix Supplied
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
CELLPAD MEDICAL GRADE SILICONE GEL MATRIX
elastomer, silicone, for scar management patchProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:72678-005 Route of Administration TOPICAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72678-005-01 2 in 1 CARTON 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 PREMARKET NOTIFICATION K003948 08/22/2019 Labeler - NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY (967054623)