PANOXYL- benzoyl peroxide cream

PanOxyl by

Drug Labeling and Warnings

PanOxyl by is a Otc medication manufactured, distributed, or labeled by Stiefel Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

PANOXYL 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0145-2660
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	58.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0145-2660-05	1 in 1 CARTON	03/25/2011	10/31/2020
1		170.1 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0145-2660-62	20 in 1 CARTON	03/25/2011	10/31/2020
2	NDC: 0145-2660-61	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/25/2011	10/31/2020

PANOXYL 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0145-0985
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	146.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0145-0985-05	1 in 1 CARTON	03/25/2011	10/31/2020
1		156 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/25/2011	10/31/2020

Labeler - Stiefel Laboratories Inc (808842343)