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

Back

Side

NDC 0496-0732-04 Analpram AdvancedTM Kit 1 oz

NDC 0496-0730-33 Analpram AdvancedTM Kit Sample

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: 08/2010Ferndale Laboratories, Inc.