PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 16571-723-60 Rising®
(mafenide acetate cream, USP)
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.
| 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 || |
|# ||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.
| 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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