SULFAMYLON®
(mafenide acetate, USP)
FOR 5% TOPICAL SOLUTION
STERILE
Rx only
DESCRIPTION
Mafenide acetate, USP is a synthetic antimicrobial agent designated chemically as α-amino- p -toluenesulfonamide monoacetate. It has the following structural formula:
Mafenide acetate, USP is a white, crystalline powder which is freely soluble in water.
SULFAMYLON® For 5% Topical Solution is provided in packets containing 50 g of sterile mafenide acetate to be reconstituted in 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of mafenide acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution is not for injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable.
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