Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
IGI Laboratories
Medimetriks Pharmaceuticals Inc.
011036910
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sumadan
Product Details
NDC Product Code
43538-191Effective Date
December 16, 2020Sumadan Wash
Product Details
NDC Product Code
43538-190Route of Administration
TOPICALEffective Date
December 16, 2020SulfacetamideActive
Code: 4NRT660KJQClass: ACTIBQuantity: 90 mg in 1 g
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
caprylyl glycolInactive
Code: 00YIU5438UClass: IACT
SulfurActive
Code: 70FD1KFU70Class: ACTIBQuantity: 45 mg in 1 g
Alkyl (C12-15) BenzoateInactive
Code: A9EJ3J61HQClass: IACT
dimethiconeInactive
Code: 92RU3N3Y1OClass: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4Class: IACT
hexylene glycolInactive
Code: KEH0A3F75JClass: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
lemon oilInactive
Code: I9GRO824LLClass: IACT
magnesium nitrateInactive
Code: 77CBG3UN78Class: IACT
magnesium aluminum silicateInactive
Code: 6M3P64V0NCClass: IACT
magnesium chlorideInactive
Code: 02F3473H9OClass: IACT
nonoxynol-20Inactive
Code: 60ZT1XYO5NClass: IACT
methylisothiazolinoneInactive
Code: 229D0E1QFAClass: IACT
methylchloroisothiazolinoneInactive
Code: DEL7T5QRPNClass: IACT
niacinamideInactive
Code: 25X51I8RD4Class: IACT
octoxynol-5Inactive
Code: TJ327E1R1VClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
PEG-100 stearateInactive
Code: YD01N1999RClass: IACT
sodium methyl cocoyl taurateInactive
Code: JVL98CG53GClass: IACT
phenoxyethanolInactive
Code: HIE492ZZ3TClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
sodium thiosulfateInactive
Code: HX1032V43MClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
xanthan gumInactive
Code: TTV12P4NEEClass: IACT
cetyl alcoholInactive
Code: 936JST6JCNClass: IACT
cholesterolInactive
Code: 97C5T2UQ7JClass: IACT