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
NDC Product Code11344-965
Application NumberM016
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 7, 2025
Generic NameColloidal oatmeal
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