CLEARASIL DAILY CLEAR TINTED ACNE TREATMENT- benzoyl peroxide cream

Clearasil by

Drug Labeling and Warnings

Clearasil by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

• 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.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• 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

• keep tightly closed
• store at 20-25 °C (68-77 °F)

Inactive ingredients

Water, Propylene Glycol, Aluminium Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Simethicone, Methylparaben, Carbomer, Potassium Hydroxide, Propylparaben, Titanium Dioxide, Iron Oxides

Questions?

Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: Reckitt Benckiser LLC
Parsippany, NJ 07054-0224

Made in USA © RB 2011

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

DAILY CLEAR®

Tinted Acne
Treatment Cream

Benzoyl Peroxide 10% Acne Medication

Maximum strength.
24 hour control
Clearer skin all day,
every day

TINTED

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

CLEARASIL   DAILY CLEAR TINTED ACNE TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Bentonite (UNII: A3N5ZCN45C)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Polyethylene Glycol 600 (UNII: NL4J9F21N9)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Methylparaben (UNII: A2I8C7HI9T)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylparaben (UNII: Z8IX2SC1OH)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-302-02	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/01/2011

Labeler - Reckitt Benckiser LLC (094405024)