REVIVA-SIL- elastomer, silicone, for scar management
Trifluent Pharma LLC
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RevivaSil™ Gel-Pad Kit is intended for managing hypertrophic, hyperpigmented, and keloid scar tissue.
Non-sterile product is labeled as such and supplied in protective packaging and container.
Rashes may occur on skin under gel-pad due to poor hygiene. Rashes may also result from wrapping gel-pad too tightly around skin. Stop use and ask a doctor if gel-pad is applied properly and skin irritation still occurs.
Discoloration of skin covered by gel-pad may temporarily occur in patients with darker complexions.
Do not use creams, lotions, sun block, or other silicone products on your skin when wearing gel-pad. Only apply gel-pad to clean, bare skin.
Do not apply to open wounds or third degree burns. Never use on a sutured wound until sutures have been removed or when any dermatological conditions disrupt the skin (such as a rash or burn). 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 gel-pad has been applied. Stop use and ask a doctor if product is applied properly and skin irritation still occurs. Persons with dermatological disorders should contact their doctor prior to using this product.
* Proper use, and gentle care of the gel-pad will be re-usable up to eight (8) days.
Silicone Gel Matrix Pad (3'' X 5.5'')
Engineered as a self-adhesive pad; there is no need for additional wraps or taping. The non-sticky side is smooth and soft to prevent fabrics from adhering.
Do not apply to open wounds or third degree burns. Never use on a sutured wound until sutures have been removed or when any dermatological conditions disrupt the skin (such as a rash or burn). 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 gel-pad has been applied. Stop use and ask a doctor if product is applied properly and skin irritation still occurs. Persons with dermatological disorders should contact their doctor prior to using this product.
TRIFLUENT
PHARMA®
RevivaSil™
GEL-PAD KIT
QUESTIONS OR COMMENTS:
CALL (210) 944-6920
MANUFACTURED FOR:
Trifluent Pharma, LLC
San Antonio, TX 78213
MADE IN THE U.S.A.
540-01 REV02 12-22-2023
CONTAINS:
FOUR (4) SILICONE GEL-PADS (3" X 5.5") (NON-STERILE)
ONE (1) REVIVA-E™ SOLUTION – 0.5 FL. OZ. (15 mL)
PRODUCT SHOULD BE ADMINISTERED UNDER THE
SUPERVISION OF A LICENSED MEDICAL PRACTITIONER
(CONTENTS NOT FOR INDIVIDUAL SALE OR DISTRIBUTION)
NDC 73352-540-01
REVIVA-SIL
elastomer, silicone, for scar management kit |
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Labeler - Trifluent Pharma LLC (117167281) |