ANALPRAM ADVANCED  - hydrocortisone acetate and pramoxine hydrochloride   
Ferndale Laboratories, Inc.

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Analpram Advanced Kit

HOW SUPPLIED:

Analpram AdvancedTM Kit

30 x 4 gram Kit (NDC 0496-0731-64)

1 oz Kit (NDC 0496-0732-04)

Rx Only.
Ferndale Laboratories, Inc.

Ferndale, MI 48220 U.S.A
Toll free (888) 548-0900
www.ferndalelabs.com

Analpram AdvancedTM is a trademark of Ferndale IP, Inc.

Analpram HC® is a registered trademark of Ferndale IP, Inc.

VasculeraTM and AloeCleanTM are trademarks of Primus Pharmaceuticals, Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

NDC 0496-0731-64 Analpram AdvancedTM Kit 30 x 4 gram

Front

AnalpramAdvanced30x4g


AnalpramAdvanced30x4gBack

Side

AnalpramAdvanced30x4gSide

NDC 0496-0732-04 Analpram AdvancedTM Kit 1 oz

AnalpramAdvanced1oz

NDC 0496-0730-33 Analpram AdvancedTM Kit Sample

AnalpramAdvancedSample







ANALPRAM ADVANCED 
hydrocortisone acetate and pramoxine hydrochloride   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0496-0730
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0730-33 1 KIT In 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE, WITH APPLICATOR   4 g
Part 1 of 1
ANALPRAM HC 
hydrocortisone acetate and pramoxine hydrochloride   cream
Product Information
NDC Product Code (Source) 0496-0799
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0799-33 4 g In 1 TUBE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2010

ANALPRAM ADVANCED 
hydrocortisone acetate and pramoxine hydrochloride   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0496-0731
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0731-64 1 KIT In 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 30 TUBE, WITH APPLICATOR   120 g
Part 1 of 1
ANALPRAM HC 
hydrocortisone acetate and pramoxine hydrochloride   cream
Product Information
NDC Product Code (Source) 0496-0799
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0799-64 30 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR (0496-0799-36)
1 0496-0799-36 4 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (0496-0799-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2010

ANALPRAM ADVANCED 
hydrocortisone acetate and pramoxine hydrochloride   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0496-0732
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0732-04 1 KIT In 1 CARTON None
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE, WITH APPLICATOR   28.4 g
Part 1 of 1
ANALPRAM HC 
hydrocortisone acetate and pramoxine hydrochloride   cream
Product Information
NDC Product Code (Source) 0496-0799
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0496-0799-04 28.4 g In 1 TUBE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2010

Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
Name Address ID/FEI Operations
Ferndale Laboratories, Inc. 005320536 manufacture
Revised: 08/2010 Ferndale Laboratories, Inc.