PANOXYL- benzoyl peroxide soap 
Stiefel Laboratories 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.

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Drug Facts

Active ingredient (Maximum Strength)

Benzoyl peroxide 10%

Active ingredient (Regular Strength)

Benzoyl peroxide 5%

Purpose

Acne medication

Uses

for the treatment of acne

Warnings

For external use only

Do not use

•
if you have very sensitive skin
•
are sensitive to benzoyl peroxide

When using this product

•
avoid unnecessary sun exposure and use a sunscreen
•
avoid contact with the eyes, lips, and mouth
•
avoid contact with hair and dyed fabrics, which may be bleached by this product
•
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
•
skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Stop use and ask a doctor if

•
irritation becomes severe.

Keep out of reach of children.

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

Directions

•
wet area to be cleansed. Using warm water, wash the affected area for 1 to 2 minutes
•
rinse thoroughly and pat dry
•
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
•
if bothersome dryness or peeling occurs, reduce application to once a day or every other day
•
if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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 1-888-438-7426.

Principal Display Panel

NDC 0145-0983-05

PanOxyl®

DERMATOLOGIST Recommended Ingredients

ACNE CLEANSING BAR

Maximum Strength

Benzoyl Peroxide 10%

FACE

CHEST

BACK

Deep Cleaning Bar

•
Clears existing acne blemishes and helps prevent new blemishes from forming
•
Quickly penetrates pores killing acne-causing bacteria on contact

Net wt 4 oz (113 g)

Stiefel Skin Science Solutions

For over 165 years, Stiefel Laboratories has been committed to advancing dermatology and skin science around the world.

•
With a superior understanding of the skin and what it needs. Stiefel scientists have developed advanced technologies that help people enjoy healthier, more beautiful skin.
•
Stiefel now brings its skin expertise directly to you through a wide range of skincare products to meet your daily needs.

www.panoxyl-skincare.com

PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

©2014 Stiefel Laboratories, Inc.

Dist.:

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

103933XA

Panoxyl 10% 4.0 bar carton

Principal Display Panel

NDC 0145-0982-05

PanOxyl®

5% Benzoyl Peroxide

Regular Strength

ACNE CLEANSING BAR

DERMATOLOGIST Recommended Ingredients

Therapeutic acne control

FACE

CHEST

BACK

•
Benzoyl Peroxide effectively penetrates pores killing the bacteria that cause acne
•
Clears existing acne blemishes and prevents new blemishes from forming

Stiefel Skin Science Solutions

Net Wt 4 Oz (113 g)

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

305233

Panoxyl 5 Bar
PANOXYL 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-0983
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (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:0145-0983-05113 g in 1 CARTON; Type 0: Not a Combination Product11/10/201011/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/10/201011/30/2018
PANOXYL 
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-0982
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.5 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (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:0145-0982-05113 g in 1 CARTON; Type 0: Not a Combination Product11/10/201011/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/10/201011/20/2015
Labeler - Stiefel Laboratories Inc (808842343)

Revised: 9/2019
Document Id: 683eda5e-f0f7-4480-b7c6-fa13980c0ebe
Set id: 40ce4ec5-69c2-4dec-acd0-48c13cd5e2fb
Version: 10
Effective Time: 20190912
 
Stiefel Laboratories Inc