CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT- benzoyl peroxide cream

Clearasil Stubborn Acne Control 5in1 Spot Treatment by

Drug Labeling and Warnings

Clearasil Stubborn Acne Control 5in1 Spot Treatment by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 outer box for full product information
• keep tightly closed
• store at 20-25 °C (68-77 °F)

Inactive ingredients

Water, Propylene Glycol, Aluminum Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Methylparaben, Carbomer, Potassium Hydroxide, Propylparaben

Questions?

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

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Distributed By:
RB Health (US),
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

STUBBORN ACNE CONTROL
5IN1 SPOT TREATMENT CREAM

Benzoyl Peroxide Acne Medication

FIGHTS
5
STUBBORN
ACNE
PROBLEMS

MAXIMUM STRENGTH

FIGHTS 1. BLOCKED PORES 2. PIMPLE SIZE
3. EXCESS OIL 4. ACNE MARKS 5. BLACKHEADS

Net wt. 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-438
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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-438-01	1 in 1 CARTON	12/06/2017
1		28 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	12/06/2017

Labeler - RB Health (US) LLC (081049410)