MedPath

Vytone

Vytone Cream

Approved
Approval ID

3d7278ee-2c8e-4df1-9372-d43403122945

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2023

Manufacturers
FDA

Artesa Labs, LLC

DUNS: 078786339

Products 1

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

HYDROCORTISONE ACETATE, IODOQUINOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57893-302
Product Classification
G
Generic Name
HYDROCORTISONE ACETATE, IODOQUINOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (17)

AMINOMETHYLPROPANOLInactive
Code: LU49E6626Q
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLACRILINInactive
Code: RCZ785HI7S
Classification: IACT
PALMITOYL TRIPEPTIDE-1Inactive
Code: RV743D216M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 19 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
IODOQUINOLActive
Quantity: 10 mg in 1 g
Code: 63W7IE88K8
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PPG-20 METHYL GLUCOSE ETHERInactive
Code: 3WV1T97D3K
Classification: IACT

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Vytone - FDA Drug Approval Details