DERM-SILK: Silicone Gel Pad (Keloid and Hypertrophic scars)
DERM-SILK by
Drug Labeling and Warnings
DERM-SILK by is a Other medication manufactured, distributed, or labeled by NEOMED PHARMACEUTICAL. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
DERM-SILK- elastomer, silicone, for scar management
patch
NEOMED PHARMACEUTICAL
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DERM-SILK: Silicone Gel Pad (Keloid and Hypertrophic scars)
DERM -SILK
(Silicone Gel Sheeting)
Rx only
For external use only
Not for ophthalmic use
DERM-SILK: ideally dimensioned for medium to large scars from burns, road rash, or keloid and old and new hypertrophic scars from surgery or trauma. Clinically proven to reduce, flatten, fade and smooth scars -- both old and new Helps prevent the formation of new scars
Each DERM-SILK contains: Dimethyl methyl hydrogen, methylvinyl silicone gel Organopolysiloxane
DERM-SILK - Clinical Pharmacology
The exact mechanism of silicone gel in improving the appearance of scar tissue remains unknown. However, numerous mechanisms have been suggested to explain the efficacy of silicone gel, 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
For non-invasive management of old and new hypertrophic or keloid scars resulting from burns, general surgical procedures, injuries or trauma wounds. reduce, flatten, fade and smooth scars -- both old and new Helps prevent the formation of new scars.
Contraindications
DERM-SILK is contraindicated in patients with known hypersensitivity to silicone or any of the listed ingredients.
Warnings
For external use only. Avoid contact with eyes, lips or mucous membranes. Do not apply on areas of broken skin. Do not apply on third degree burns and open wounds. Never use on sutured wound until sutures have been removed.
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 breast-feeding. Consult your doctor about the risks and benefits.
Adverse Reactions
Rarely the Pads may cause transient redness stinging, burning or irritation and normally disappear on discontinuing the medication.
DERM-SILK - Dosage and Administration
How does it work?
Scars need an "ideal healing environment," meaning the appropriate balance of moisture and maximum exposure to oxygen. DERM-SILK is a fully-encapsulating sheet - it completely covers the scar treatment site. Although the entire site is covered, DERM-SILK is semi-permeable, allowing oxygen to enter while keeping excess moisture our - the ideal environment for healing scar tissue.
1 Wash your hands and the scar area with soap and water. Dry thoroughly.
2 Cut the DERM-SILK Pad to fit the scar area so that the edges of the gel pad extend at least 1/4'' beyond the scar on all sides.
3 Peel of the strip and place the sticky side of the pad directly onto the scar. Leave on for 8-12 hours per day then remove. Do not discard them mylar release strip.
4 When not wearing the pad, place the gel pad (sticky side) back onto the mylar release strip.
5 Discard the pad and replace with a new one every 7 days.
How is DERM-SILK Supplied
DERM-SILK (Silicone Gel sheeting) is supplied in:
Four (4) Silicone gel sheeting 2 x 2.5 in (5 x 6 cm) patches – in 1 Carton
70898-635-04
Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]
Distributed by:
Neomed Pharmaceutical ,80 Cain Dr, Brentwood, NY 11717
Phone :631-524-5758
Email: info@neomedpharmaceutical.com
PRINCIPAL DISPLAY PANEL - 4 Sheet Pouch Carton
NEOMED
PHARMACEUTICALS
NDC: 70898-635-04
DERM-SILK
( LARGE )
Four (4) Silicone gel sheeting - 2'' x 2.5'' (5 x 6 cm) patches - in 1 Carton
| DERM-SILK
elastomer, silicone, for scar management patch |
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| Labeler - NEOMED PHARMACEUTICAL (048388130) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| NEOMED PHARMACEUTICAL | 048388130 | relabel | |