NDC Code(s) : 0496-0799-36, 0496-0799-65, 0496-0799-64, 0496-0799-04, 0496-0799-33
Packager : Ferndale Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Analpram HChydrocortisone acetate and pramoxine hydrochloride CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0496-0799
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE(UNII: 3X7931PO74)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE ACETATE25 mg in 1 g
PRAMOXINE HYDROCHLORIDE(UNII: 88AYB867L5)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE HYDROCHLORIDE10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID(UNII: 4ELV7Z65AP)
CETYL ALCOHOL(UNII: 936JST6JCN)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SORBIC ACID(UNII: X045WJ989B)
TROLAMINE LAURYL SULFATE(UNII: E8458C1KAA)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0496-0799-6512 in 1 CARTON
1NDC:0496-0799-364 g in 1 TUBE, WITH APPLICATOR Type 1: Convenience Kit of Co-Package
2NDC:0496-0799-6430 in 1 CARTON
2NDC:0496-0799-364 g in 1 TUBE, WITH APPLICATOR Type 1: Convenience Kit of Co-Package
3NDC:0496-0799-0428.4 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
4NDC:0496-0799-334 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/15/2009

PRINCIPAL DISPLAY PANEL

NDC 0496-0799-04 Analpram HC® Cream 2.5% 1 oz


AnalpramHC1oz


PRINCIPAL DISPLAY PANEL

NDC 0496-0799-65 Analpram HC® Cream 2.5% 12 x 4g


AnalpramHC12x4g



PRINCIPAL DISPLAY PANEL

NDC 0496-0799-64 Analpram HC® Cream 2.5% 30 x 4g


AnalpramHC30x4g