| ACTIVE INGREDIENT AND STRENGTH | 8.500 MAFENIDE PERCENTAGE, W/W |
| ADMINISTRATION | TOPICAL |
| MEDICAL DESIGNATION AND GRADE | UNITED STATES PHARMACOPEIA |
| MEDICAMENT BASE TYPE | EMULSION BASE, OIL-IN-WATER |
| PART NAME ASSIGNED BY CONTROLLING AGENCY | SULFAMYLON CREAM BRAND OF MAFENIDE ACETATE CREAM USP 4OZ TUBE |
| PRIMARY CONTAINER CONTENT QUANTITY | 4.000 OUNCES |
| PRIMARY CONTAINER TYPE | TUBE |
| SPECIAL FEATURES | EACH GRAM OF SULFAMYLON CREAM CONTAINS MAFENIDE ACETATE EQUIVALENT TO 85 MG OF THE BASE; FOR USE AS ADJUNCTIVE ANTIMICROBIAL BURN THERAPY FOR PATIENTS WITH SECOND AND THRID DEGREE BURNS; EXERTS BACTERIOSTATIC ACTION AGAINST MANY GRAM-NEGATIVE AND GRAM-POSTIVE ORGANISMS, INCLUDING PSEUDOMONAS AERUGINOSA AND CERTAIN STRAINS OF ANAEROBES; NONSTAINING; AVOID EXPOSURE TO EXCESSIVE HEAT ABOVE 104 DEGREES F OR 40 DEGREES C |
| TOTAL PRIMARY CONTAINER QUANTITY | 1 |
| SUPPLEMENTARY FEATURES | MAFENIDE CREAM |