Carrington Laboratories receives additional 510(K) approval for the Carrington(TM) patch.IRVING, Texas--(BUSINESS WIRE)--May 1, 1996--Carrington Laboratories, Inc., (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CARN) announced that it has received an additional 510(K) clearance from the Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for The Carrington(TM) patch, a freeze-dried product previously granted a 510(K) for the management of aphthous ulcers (canker sores Canker Sores Definition Canker sores are small sores or ulcers that appear inside the mouth. They are painful, self-healing, and can recur. Description ). The new indications include all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa (including traumatic ulcers), such as those caused by braces and ill-fitting dentures. These additional indications enable Carrington to market The Carrington(TM) Patch to a wider audience. The patch contains no alcohol to sting, nor numbing agents such as benzocaine benzocaine /ben·zo·caine/ (-kan) a local anesthetic applied topically to the skin and mucous membranes; also used to suppress the gag reflex in various procedures. ben·zo·caine n. . It can provide pain relief for up to six hours as it slowly rehydrates into a gel that can be safely swallowed. The Carrington(TM) Patch, in a previous 510(K), was marketed for the cessation of pain associated with canker sores. The new 510(K) recognizes cessation-of-pain claims for the additional indications. The patch provides a protective film or cover over an ulcer, adheres to tissue in the oral cavity and protects ulcerated Ulcerated Damaged so that the surface tissue is lost and/or necrotic (dead). Mentioned in: Adenoid Hyperplasia tissue from further irritation. This expanded version of The Carrington(TM) Patch launches a line of specially formulated oral products being developed by Carrington. In March, The Carrington(TM) Patch was introduced nationally on the Home Shopping Network “HSN” redirects here. For other uses, see HSN (disambiguation). The Home Shopping Network (HSN) is a mostly 24-hour shopping network that is seen on cable, satellite, and some terrestrial channels in the United States. (HSN) as a product for the management of canker sores and cessation of their pain. The product was featured again this morning on HSN only for aphthous ulcers. It will air again tomorrow morning (May 2) at 7:20 a.m. EDT with the additional label claims. Dr. Janelle Bicknell, D.D.S., who will be the spokesperson on Home Shopping Network is a Grand Prairie, Texas-based dentist. She was a participant in various aphthous ulcer research studies done at Baylor College of Dentistry Baylor College of Dentistry (BCD), located in east Dallas, Texas (USA), is the dental education unit of the Texas A&M University System, and a component of the Texas A&M Health Science Center. in Dallas which helped develop The Carrington(TM) Patch. Dr. Bicknell will speak about mouth irritations (such as canker sores) as a researcher, as a sufferer, as a dental professional and as "mom." Commenting on the approvals, Carlton E. Turner, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said, "This further recognition of the value of our oral technology products reinforces our continued commitment to provide additional products to the public from natural sources that are taste-free and safe when used in the mouth." Carrington Laboratories, Inc., is an emerging research-based pharmaceutical and medical device company engaged in developing complex carbohydrate-based therapeutics and in manufacturing and marketing products for the management of wounds. Carrington currently has more than 40 products on the market. CONTACT: Carrington Laboratories Inc., Dallas Chris Record, 214/518-1300 or Blackmore & Co., Dallas Jim Blackmore, 214/988-3736 |
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