MAXCLARITY - benzoyl peroxide aerosol, foam
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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Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne medication

Use

For the treatment of acne

Warnings

For external use only

Do not use

if you have very sensitive skin or if you 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 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.
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.

Keep out of reach of children.

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

FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Directions (Advanced Acne Treatment)

Clean the area thoroughly before applying this product.
Shake can before use.
Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball).
Using fingers, cover the entire affected area with a thin layer 1 to 3 times daily.
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, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Directions (Deep Cleanser)

Wet area to be cleaned.
Shake can before use.
Invert can and then press firmly to dispense a small amount of foam (not more than a dollop the size of a golf ball).
Apply and gently massage area for 1 to 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, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Other information

Store at 68° to 77°F (20° to 25°C). Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive ingredients (Advanced Acne Treatment)

benzyl alcohol, ceteareth-20, citric acid, disodium EDTA, purified water, sodium citrate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).

Inactive Ingredients (Deep Cleanser)

citric acid, disodium EDTA, purified water, sodium citrate, sodium lauryl sulfate, and xanthan gum pressurized with a hydrocarbon (propane/isobutane/butane propellant).

Questions?

call 1-888-784-3335 (1-888-STIEFEL). Side effects may be reported to this number.

Principal Display Panel

NDC 0145-2842-02

MaxClarity™

foam acne medication

Advanced Acne Treatment

with VersaFoam® Technology

Benzoyl Peroxide 2.5%

Net Wt 2.64 Oz (75 g)

MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc.

www.maxclarity.com

To reorder call 877-LIKE-MAX

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION

CFC FREE

10000000093323

MaxClarity Advanced Acne Treatment label

Principal Display Panel

NDC 0145-2840-02

MaxClarity™

foam acne medication

Deep Cleanser

with VersaFoam® Technology

Benzoyl Peroxide 2.5%

Net Wt 2.64 Oz (75 g)

MAXCLARITY is a trademark and VERSAFOAM is a registered trademark of Stiefel Laboratories, Inc.

www.maxclarity.com

To reorder call 877-LIKE-MAX

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

DELIVERED IN VersaFoam-AF™ AQUEOUS FORMULATION

CFC FREE

10000000093321

MaxClarity Deep Cleanser label

MAXCLARITY
benzoyl peroxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0145-2842
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	25 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
WATER
SODIUM CITRATE
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0145-2842-02	75 g in 1 CAN	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	06/22/2011

MAXCLARITY
benzoyl peroxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0145-2840
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	25 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
WATER
SODIUM CITRATE
SODIUM LAURYL SULFATE
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0145-2840-02	75 g in 1 CAN	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	06/22/2011

Labeler - Stiefel Laboratories Inc (808842343)

Revised: 06/2011 Stiefel Laboratories Inc