PANOXYL - benzoyl peroxide soap 
Physicians Total Care, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient (Maximum Strength)

Benzoyl peroxide 10%

Active ingredient (Regular Strength)

Benzoyl peroxide 5%

Purpose

Acne medication

Use for the treatment of acne; helps prevent new acne blemishes from forming

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at controlled room temperature 59° -86°F (15°-30°C).

Inactive ingredients

cetearyl alcohol, cocamidopropyl betaine, glycerin, hydrogenated castor oil, lactic acid, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, silica, sodium lauryl sulfate, titanium dioxide, zea mays (corn) starch

Questions?

call 1-888-784-3335 (STIEFEL). Side effects associated with use of this product may be reported to this number.

Maximum Strength

Now you can take control of your acne with Maximum Strength PanOxyl® Acne Cleansing Bar, the highest strength of Benzoyl Peroxide (BPO) available without a prescription. The Benzoyl Peroxide in the PanOxyl® Acne Cleansing Bar is the same medicine prescribed by dermatologists.

The convenient bar form of PanOxyl® gently removes dirt and excess oil to cleanse and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

Regular Strength

 Now you can take control of your acne with the PanOxyl® Acne Cleansing Bar. The 5% Benzoyl Peroxide in the PanOxyl® Acne Cleansing Bar is the same medicine prescribed by dermatologists.

The convenient bar form of PanOxyl® Acne Cleansing Bar gently removes dirt and excess oil to cleanse and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

www.stiefelchc.com

©2010 Stiefel Laboratories, Inc.

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Relabeling by:
Physicians Total Care, Inc.
Tulsa, OK     74146


Principal Display Panel

NDC 54868-2656-0

PanOxyl®

10% Benzoyl Peroxide

Maximum Strength

ACNE CLEANSING BAR

DERMATOLOGIST Recommended Ingredients

Therapeutic acne control

FACE

CHEST

BACK


Net Wt 4 Oz (113 g)

image of  Panoxyl 10% Bar carton label

Principal Display Panel

NDC 54868-2655-0

PanOxyl®

5% Benzoyl Peroxide

Regular Strength

ACNE CLEANSING BAR

DERMATOLOGIST Recommended Ingredients

Therapeutic acne control

FACE

CHEST

BACK


Net Wt 4 Oz (113 g)

image of Panoxyl 5% Bar Carton label
PANOXYL 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2656(NDC:0145-0983)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE11.3 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LACTIC ACID (UNII: 33X04XA5AT)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE (UNII: B7862WZ632)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2656-01 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D03/31/2008
PANOXYL 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2655(NDC:0145-0982)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5.65 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LACTIC ACID (UNII: 33X04XA5AT)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE (UNII: B7862WZ632)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2655-01 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D03/31/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 5/2011
Document Id: d0858161-2ad5-447c-8e65-b63cec7e918f
Set id: 41aac3a5-ce01-435f-948a-668e68802bb9
Version: 1
Effective Time: 20110520
 
Physicians Total Care, Inc.