Eczema Soothing Moisturizing Cream
Swan_Simply U 965.001/965AC Eczema Soothing Moisturizing Cream
Approved
Approval ID
23548524-2e2e-4d1a-9ebb-6f86d6279e93
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Consumer Product Partners, LLC
DUNS: 119091520
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colloidal oatmeal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11344-965
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal oatmeal
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (16)
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
OAT KERNEL OILInactive
Code: 3UVP41R77R
Classification: IACT
STEARETH-20Inactive
Code: L0Q8IK9E08
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CERAMIDE 3Inactive
Code: 4370DF050B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DISTEARYLDIMONIUM CHLORIDEInactive
Code: OM9573ZX3X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
OATMEALActive
Quantity: 10 mg in 1 g
Code: 8PI54V663Y
Classification: ACTIB