It is one of the only Rx products currently available in the US market specifically indicated for Radiation Dermatitis.
The FDA approval process for medical devices is determined by risk classification. KeraStat® Cream received pre-market clearance as an “Unclassified” topical cream product. Under the FDA 510(k) medical device regulatory pathway, the product underwent a review process resulting in a “Cleared” designation. This assessment, like drug approvals in scope, involves a full panel review by the FDA.
This device, KeraStat® Cream, is available by prescription only.
- FDA-cleared number K192386.
NDC number designation for 1 oz. tubes is 60006093401 - ICD-10 Code: L589 Radiodermatitis, unspecified
- ICD-9 Code: 69282 Radiodermatitis, unspecified
Note to Doctors: KeraStat® Cream is best used prophylactically by applying to the radiated skin as soon as after the first dose.
Patients who are having symptoms of radiotherapy induced dermatitis (radiation dermatitis) and patients who will be receiving radiotherapy in the future can get sample instructions here to give to your healthcare provider.