Policy responses and statements
Background: The MHRA circulated Consultation ARM 38 which sought views on a proposal to reclassify Orajel Mouth Gel (Benzocaine 10%) from P to GSL. Orajel Mouth Gel is for temporary relief from the pain and tenderness associated with mouth ulcers or from wearing dentures. Topical Benzocaine gel preparations have been marketed in the USA for over 60 years and in the UK for over 40 years. Orajel Dental Gel has been available as a P product in the UK for 5 years and was the subject of a P to GSL Reclassification in October 2005. Orajel Mouth Gel, which also has 10% Benzocaine in a similar gel formulation, has been on the UK market since April 2001, initially as Orajel Denture and, since October 2005, as Mouth Gel. There are adequate data to demonstrate that Orajel Mouth Gel also fulfils the criteria required to change the legal status of a product from P to GSL.
Download this consultation response as a .pdf
Copies of this response are available from: Lesley Lockhart, Tel: 0131 225 7324 ext 608 [5 February 2007]
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