Lidocaine HCl - Hydrocortisone Acetate
Prescribing Information
Approved
Approval ID
ac6c6117-97cc-4b7a-a831-03fb23a54b70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2018
Manufacturers
FDA
PureTek Corporation
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine HCl and Hydrocortisone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-816
Product Classification
G
Generic Name
Lidocaine HCl and Hydrocortisone Acetate
Product Specifications
Route of AdministrationRECTAL
Effective DateDecember 19, 2018
FDA Product Classification
INGREDIENTS (24)
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 g
Code: V13007Z41A
Classification: ACTIR
HYDROCORTISONE ACETATEActive
Quantity: 20 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
ALUMINUM SULFATEInactive
Code: 34S289N54E
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT