30 August 1993
14 October 1988
COMMERCIAL ITEM DESCRIPTION
BENZOCAINE ORAL TOPICAL SOLUTION
The General Services Administration has authorized the use of this Commercial Item Description.
Shall be Benzocaine Oral Topical Solution.
All ingredients shall be of pharmaceutical grade.
Shall be a solution containing 20 percent Benzocaine in a sugar free, water soluble polyethylene glycol base suitable for use in the oral mucosa.
Shall contain not less than 90.0 percent and not more than 100.0 percent of the required amount of Benzocaine, when tested by a suitable, accurate and reproducible method.
The solution shall meet the requirements for absence of Staphylococcus aureus and Pseudomonas aeruginosa under Microbial Limit Test (61) in the USP.
The solution shall have stability data acceptable to FDA to support a minimum of three year shelf life.
Workmanship. The solution shall be free from defects which detract from its appearance or impair its serviceability.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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