Analpram HC
Analpram HC (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
Approved
Approval ID
fecf8380-3bb5-11e5-98c5-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Sebela Pharmaceuticals Inc.
DUNS: 079104574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone acetate and pramoxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54766-799
Product Classification
G
Generic Name
hydrocortisone acetate and pramoxine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (11)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
TRIETHANOLAMINE LAURYL SULFATEInactive
Code: E8458C1KAA
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 25 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 88AYB867L5
Classification: ACTIB