Proctofoam
proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%)
Approved
Approval ID
14e43813-665c-4cef-b3b1-60eafc880f41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-982
Application NumberANDA086195
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone acetate and pramoxine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 5, 2010
FDA Product Classification
INGREDIENTS (10)
hydrocortisone acetateActive
Quantity: 100 mg in 10 g
Code: 3X7931PO74
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
trolamineInactive
Code: 9O3K93S3TK
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
isobutaneInactive
Code: BXR49TP611
Classification: IACT
propaneInactive
Code: T75W9911L6
Classification: IACT
pramoxine hydrochlorideActive
Quantity: 100 mg in 10 g
Code: 88AYB867L5
Classification: ACTIB