SULFAMYLON (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16571-723-60 Rising®
SULFAMYLON® Cream
(mafenide acetate cream, USP)
Rx only
2 oz. (56.7 g) For Topical Use Only

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.

mafenide-2oz-carton-label
(click image for full-size original)
SULFAMYLON mafenide acetate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16571-723
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAFENIDE ACETATE (MAFENIDE) MAFENIDE 85 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
STEARYL ALCOHOL
POLYOXYL 40 STEARATE
PEG-8 STEARATE
GLYCERIN
WATER
METHYLPARABEN
PROPYLPARABEN
SODIUM METABISULFITE
EDETATE DISODIUM
Product Characteristics
Color WHITE (soft white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16571-723-48 453.6 g in 1 JAR None
2 NDC:16571-723-12 1 TUBE in 1 CARTON contains a TUBE
2 113.4 g in 1 TUBE This package is contained within the CARTON (16571-723-12)
3 NDC:16571-723-60 1 TUBE in 1 CARTON contains a TUBE
3 56.7 g in 1 TUBE This package is contained within the CARTON (16571-723-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016763 05/18/2020
Labeler — Rising Pharma Holdings, Inc. (116880195)
Establishment
Name Address ID/FEI Operations
Kavis Pharma LLC 119014974 ANALYSIS (16571-723), LABEL (16571-723), MANUFACTURE (16571-723), PACK (16571-723)

Revised: 07/2023 Rising Pharma Holdings, Inc.

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