Sulfamylon Cream

SULFAMYLON Cream, applied topically, produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction in bacterial growth after application of SULFAMYLON Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to fullthickness. It should be noted, however, that delayed eschar separation has occurred in some cases.

Absorption And Metabolism

Applied topically, SULFAMYLON Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (ρ-carboxybenzenesulfonamide) which is cleared through the kidneys. SULFAMYLON is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment.

Antibacterial Activity

SULFAMYLON exerts bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and certain strains of anaerobes.

You should not use this medication if you are allergic to mafenide.

Before using mafenide, tell your doctor if you are allergic to any drugs (especially sulfa drugs), or if you have:

• kidney disease; or
• glucose-6-phosphate dehydrogenase (G6PD) deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether mafenide passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with mafenide.

Your pharmacist can provide more information about mafenide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Sulfamylon Cream is a soft, white, nonstaining, water-miscible, anti-infective cream for topical administration to burn wounds.

Sulfamylon Cream spreads, easily, and can be washed off readily with water. It has a slight acetic odor. Each gram of Sulfamylon Cream contains mafenide acetate equivalent to 85 mg of the base. The cream vehicle consists of cetyl alcohol, steryl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate, glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate disodium as preservatives.

Chemically, mafenide acetate is α-Amino-ρ-toluenesulfonamide monoacetate and has the following structural formula:

Sulfamylon Cream, applied topically, produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns. Reduction in bacterial growth after application of Sulfamylon Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. It should be noted, however, that delayed eschar separation has occurred in some cases.

Absorption and Metabolism

Applied topically, Sulfamylon Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (ρ-carboxybenzenesulfonamide) which is cleared through the kidneys. SULFAMYLON is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment.

Antibacterial Activity

SULFAMYLON exerts bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and certain strains of anaerobes.

Sulfamylon Cream is a topical agent indicated for adjunctive therapy of patients with second- and third- degree burns.

16 oz. Plastic Jar (453.6 g) - NDC 51079-623-83
4 oz. Tube (113.4 g) - NDC 51079-623-82
2 oz. Tube (56.7 g) - NDC 51079-623-81

Avoid exposure to excessive heat (temperature above 104° F or 40° C).

For External Use Only.

Keep this and all medications out of the reach of children.

Rx only

Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

REVISED JULY 2013
030.4

PRINCIPAL DISPLAY PANEL - 2 oz.

NDC 51079-623-81

SULFAMYLON®
CREAM (mafenide acetate
cream, USP)

For Topical Use Only

Rx only   2 oz. (56.7 g)

Mylan Institutional Inc.
Rockford, IL 61103 U.S.A

MI:623:81:1C:R6
523.6

Each gram contains mafenide acetate equivalent to 85 mg base in a water-miscible cream
of cetyl alcohol, stearyl alcohol, cetyl esters wax, polyoxyl 40 stearate, polyoxyl 8 stearate,
glycerin, and water, with methylparaben, propylparaben, sodium metabisulfite, and edetate
disodium as preservatives.

For dosage and administration, read accompanying package insert.
Avoid exposure to excessive heat (temperatures above 104°F or 40°C).
For external use only.
Keep this and all medications out of the reach of children.