Lidocaine Hydrochloride and Hydrocortisone Acetate
Lidocaine 3% - Hydrocortisone 0.5% Cream Kit
Approved
Approval ID
6aa284d6-0212-4fb5-809d-c721aa6fe2ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2024
Manufacturers
FDA
Seton Pharmaceuticals
DUNS: 828898002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride and Hydrocortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13925-165
Product Classification
G
Generic Name
Lidocaine Hydrochloride and Hydrocortisone Acetate
Product Specifications
Route of AdministrationRECTAL
Effective DateFebruary 17, 2019
FDA Product Classification
INGREDIENTS (20)
LIDOCAINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 g
Code: V13007Z41A
Classification: ACTIR
HYDROCORTISONE ACETATEActive
Quantity: 5 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ALUMINUM SULFATEInactive
Code: 34S289N54E
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PEG-150 DISTEARATEInactive
Code: 6F36Q0I0AC
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT