PANOXYL- benzoyl peroxide cream 
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 (4%)

Benzoyl peroxide 4%

Active ingredient (10%)

Benzoyl peroxide 10%

Purpose

Acne medication

Use

•
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

•
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
•
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.

Stop use and ask a doctor if

•
irritation becomes severe

If pregnant or breast-feeding,

ask a health professional before use.

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
•
apply acne wash and gently massage area for 1-2 minutes
•
rinse thoroughly and pat dry
•
because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 below 25°C (77°F). Do not freeze.

Inactive ingredients 4%

carbomer, decyl glucoside, diethylhexyl sodium sulfosuccinate, dimethicone, glycerin, palmitic acid, PEG-40 stearate, polyacrylate crosspolymer-6, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium lauryl glucosides hydroxypropyl sulfonate, sorbitan stearate, sorbitol, stearic acid, t-butyl alcohol, xanthan gum

Inactive ingredients 10%

carbomer, decyl glucoside, diethylhexyl sodium sulfosuccinate, dimethicone, glycerin, palmitic acid, PEG-40 stearate, polyacrylate crosspolymer-6, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium lauryl glucosides hydroxypropyl sulfonate, sorbitan stearate, stearic acid, t-butyl alcohol, xanthan gum

Questions or comments?

call 1-888-438-7426

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.

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

Stiefel

Skin Science Solutions

Distributed by: Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

TAMPER-EVIDENT FEATURE: For your protection, do not use if foil seal on tube is broken or missing.

Principal Display Panel

NEW FORMULA

NDC 0145-2660-05

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE CREAMY WASH

Benzoyl Peroxide 4%

Daily Control

Daily Cleaning Wash

Face

Chest

Back

•
Clears existing acne blemishes and helps prevent new blemishes from forming
•
Formulated to be gentle on skin
•
Contains benzoyl peroxide, an antibacterial ingredient
•
Patent Pending Acne Control Formula

NET WT 6 oz (170 g)

105777XB

105777XB_Panoxyl_0.04.JPG

Principal Display Panel

NEW FORMULA

NDC 0145-0985-05

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE FOAMING WASH

Benzoyl Peroxide 10%

Maximum Strength

Deep Cleaning Wash

Face

Chest

Back

•
Clears existing acne blemishes and helps prevent new blemishes from forming
•
Formulated to be gentle on skin
•
Contains benzoyl peroxide, an antibacterial ingredient
•
Patent Pending Acne Control Formula

NET WT 5.5 oz (156 g)

105776XB

105776XB_Panoxyl_0.10.JPG
PANOXYL 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-2660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE58.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0145-2660-051 in 1 CARTON03/25/201110/31/2020
1170.1 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0145-2660-6220 in 1 CARTON03/25/201110/31/2020
2NDC:0145-2660-615 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/25/201110/31/2020
PANOXYL 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-0985
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE146.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0145-0985-051 in 1 CARTON03/25/201110/31/2020
1156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/25/201110/31/2020
Labeler - Stiefel Laboratories Inc (808842343)

Revised: 11/2018
Document Id: da05be93-bb92-461b-bed9-a8dbdce3bc70
Set id: 83850837-c5fd-459f-8d4e-9ffb8b52a64e
Version: 14
Effective Time: 20181119
 
Stiefel Laboratories Inc