MedPath

Not Applicable

ProtexaUrea 42% CreamRx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Approved
Approval ID

78f23668-5590-4a4e-9547-272ddc70af3a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 18, 2020

Manufacturers
FDA

Sterling-Knight Pharmaceuticals, LLC

DUNS: 079556942

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Protexa

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69336-810
Product Classification
G
Generic Name
Protexa
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 18, 2020
FDA Product Classification

INGREDIENTS (15)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
UreaActive
Quantity: 42 mg in 1 g
Code: 8W8T17847W
Classification: ACTIB
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
PhenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
AloeInactive
Code: V5VD430YW9
Classification: IACT
PEG-100 StearateInactive
Code: YD01N1999R
Classification: IACT
EthylhexylglycerinInactive
Code: 147D247K3P
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
CITRIC ACID ACETATEInactive
Code: DSO12WL7AU
Classification: IACT

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Not Applicable - FDA Drug Approval Details