81N-0033
SUP 8
Volume 72

Cover Letter

List of References

Reference 1 - Department of Health and Human Resources, 2 1 CFR Parts 356 and 369, Docket No.
81N-0033, Oral Health Care Drug Products for the Over-the-Counter Human Use; Amendment to Tentative Final Monograph to Include OTC Relief of Oral discomfort Drugs. September 24, 1991

Reference 2 - Department of Health and Human Services, Docket No. 00N-1256; Over-The-Counter Drug Products Public Hearing, April 27, 2000.

Reference 3 - Department of Health and Human Services, (cite: 21CFR 3 10.201) Subpart C- New Drugs Exempted from Prescription - Dispensing Requirements., April 1, 2003.

Reference 4 - Gargiulo, AV, Burns, GM and Huck, CP. "Dyclonine hydrochloride-a topical agent for managing pain.” Illinois Dental Journal, July/August 1992, pp. 303-304.

Reference 5 - Gargiulo, AV, Bianco, CP, Burns, GM and Majcina, L.. “A research study using dyclonine hydrochloride 0.5% as a topical anesthetic for debridement.” Journal of Practical Hygiene. Special Supplement, March/April, 1998: pp. l-5.

Reference 6 - Gargiulo, AV, Solt, D.. “Use of Dyclonine Hydrochloride 0.5% as anesthetic in Oral soft tissue biopsies”. Journal of Practical Hygiene. Special Supplement, March/April, 1998: pp. 6-9.

Reference 7 - Ping, RS, White, JG, Spear, LB.. “Dyclonine hydrochloride as a topical anesthetic in dentistry." Oral Surgery Oral Medicine Oral Pathology 1957; 10: 623-626.

Reference 8 - Adriani, J, Beuttler, WA, et al.. ‘Topical anesthetics: Use and misuse.” Southern Medical Journal 1985; 78: 1224-1229.

Reference 9 - Adriani, J. et al.. “Scope and limitations of topical anesthetics in anesthesiology.” Anesthesiology Rev. 1983 10: 10-15.

Reference 10 - Dyclone, Product Insert Data, Astra Pharmaceutical Co. Inc. Westborough, Mass. 01581.

Reference 11 - Groeben H. Grosswendt T. , et al.. “Airway anesthesia alone des not explain attenuation of histamine induced bronehospasm by local anesthetics: a comparison of lidocaine, ropivacaine and dyclonine.” Anesthesiology 2001; 94: 423-428.

Reference 12 - Bhagat, HR. et al. “High performance liquid chromatographic determination of dyclonine hydrochloride in the presence of its degradation groducts,” Deparment of Chemistry, Massachusetts College of Pharmacy and Allied Health Sciences, Boston, Mass., 1995.

Reference 13 - Adriani, J and Zepemick, R.. “Clinical effectiveness of drtrgs used for topical anesthesia.” Journal of the American Mpdical Association, 1964; 88: 711-716.