Damor America/Farmaceutici Damor.

Damor America/Farmaceutici Damor, Naples, Italy, May 14, 1998 (CDRH-OC). In a letter addressed to the Washington law firm, Hogan & Hartson, FDA criticized a flyer promoting Damor Creme and Damor Saturated Dressing for unapproved uses, such as "accelerated healing, decreased bacterial growth, scar reduction [and] increased growth of skin cells," along with treating dermatitis, eczema, psoriasis, insect bites and venous stasis ulcers. According to the 510(k), the products were "intended to protect wounds from drying and to help maintain favorable conditions for the local management of decubitous ulcers, first- and second-degree burns, lacerations, skin abrasions and severe sunburn," the letter said. In ad-dition, the "510(k) clearance letters contained a caveat against making claims" for accelerated healing, according to FDA. The agency added that implied claims for preventing infections required an NDA and inaccurately represented 2-phenox-yethanol as an antibiotic and antifungal, when it is actually an antibacterial agent. Furthermore, the brochure falsely stated that the products were available without a prescription and lacked risk information, FDA said.