[INCH-POUND]
A-A-5200A
30 August 1993
SUPERSEDING
A-A-0051200(DM)
01 June 1987
COMMERCIAL ITEM DESCRIPTION
BENZOCAINE ORAL TOPICAL GEL
The General Services Administration has authorized the use of this Commercial Item Description.
Salient characteristics:
Shall be Benzocaine Oral Topical Gel.
All ingredients shall be of a pharmaceutical grade.
Shall be a pleasantly flavored, palatable gel containing 20 percent w/w Benzocaine in a sugar free, water soluble polyethylene glycol base suitable for use on the oral mucosa.
Shall contain not less than 90.0 percent and not more than 110.0 percent of the required amount of Benzocaine, when tested by a suitable, accurate and reproducible method.
The gel shall meet the requirements for absence of Staphylococcus aureus and Pseudomonas aeriginosa under Microbial Limit Test (61) in the USP.
The gel shall have stability data acceptable to FDA to support a minimum of three year shelf life.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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