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
NDC Product Code13925-165
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationRECTAL
Effective DateFebruary 17, 2019
Generic NameLidocaine Hydrochloride and Hydrocortisone Acetate
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