DESCRIPTION

Antiscar is a prescription topical patch containing 15 medicated patches (5 patches per resealable envelope X3 per box of 15). Antiscar patch is comprised of an adhesive material containing petrolatum, allantoin, retinoic acid, onion extract, and EGCG (epigallocatechin gallate) which is applied to the backing of an articulated patch. One patch is pulled from the resealable envelop, the PET film removed, and the sticky side is applied to the site. Petrolatum is present in a 3% concentration. Allantoin, also called 5-ureidohydantoin or glyoxyldiureide, is present in a 2.0% concentration. Retinoic acid, also referred to as all-trans-retinoic acid (ATRA), is present in a 2% concentration. The chemical designation is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-yl)-2,4,6,8-nonatetraenoic acid. Onion extract gel, also referred to as Allium cepa L., is present in a 0.5% concentration. Epigallocatechin gallate (EGCG), also known as epigallocatechin-3-gallate, is present in a 0.5% concentration.

INDICATION AND USAGE

Antiscar medicated patch is a formulation used for patients greater than 12 years in age to assist in temporary support of wound healing, minor cuts, scrapes and burns while improving scar appearance. One patch should be administered to the wound or scar site every 8 hours or twice daily.

CONTRAINDICATIONS

Known hypersensitivity to paraben, retinoid, onion extract or any component of the product. Pregnancy (see pregnancy section)

WARNINGS AND PRECAUTIONS

Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label.

• Accidental Exposure in Children: the potential exists for a small child or a pet to suffer adverse effects from chewing or ingesting a new or used Antiscar patch. It is important for patients to store and dispose of Antiscar patchs out of the reach of children and pets.
• For external use only.
• The Antiscar patch should not be used if there are mental or physical conditions that may preclude compliance with physician instructions

PREGNANCY:
The safety of Antiscar patch has not been established during pregnancy. Teratogenesis is a serious concern with oral retinoic acid as vitamin A analogs are well-known teratogens. Teratogenic and embryotoxic effects have been demonstrated in animals receiving oral retinoic acid. It is expected that retinoic acid will cause fetal harm when administered to a pregnant woman and that there is a high risk of producing a severely deformed infant. Adequate and well-controlled trials have not been performed in humans, but increased spontaneous fetal abortion and major human fetal abnormalities have occurred when pregnant women received other retinoids.

OVERDOSAGE:
There have been no reports of over-dosage with Antiscar patch. Signs of overdosage could include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

ADVERSE REACTIONS

The most common adverse reactions are application site reactions, including dermatitis, irritation, itching or scaling. These tend to be dose-limiting and diminish with time. About 4% of patients had to discontinue use of topical retinoic acid because of adverse reactions. If severe erythema, edema, vesicle formation (e.g., vesicular rash), or crusting develops, Antiscar should be discontinued until skin integrity is restored. Therapy may be reinitiated with less frequent application.

METABOLISM

Following topical application, a minimal amount of the active ingredients are absorbed systemically. Approximately 1—5% of a topically applied dose of retinoic acid is excreted in the urine within 24 hours. Systemic retinoic acid is greater than 95% bound to plasma proteins, primarily albumin. Retinoic acid is metabolized by the cytochrome P450 hepatic enzyme system. The metabolites include 13-cis retinoic acid, 4-oxo trans retinoic acid, 4-oxo cis retinoic acid, and 4-oxo trans retinoic acid glucuronide.

HOW SUPPLIED

Antiscar patch is supplied in the following dosage form:  15 medicated patches [ (5 per resealable envelope) x 3 ]

STORAGE AND HANDLING

Store at room temperature at 68°F to 77°F (20°C to 25° C). Excursion permitted to 59º-86º F (15º -30ºC). [See USP Controlled Room Temperature]. Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

PACKAGE LABEL