Clearasil® Ultra® Rapid Action Vanishing Treatment

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL  ULTRA RAPID ACTION VANISHING TREATMENT- benzoyl peroxide cream 
RB Health (US) LLC

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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Clearasil®
Ultra® Rapid Action Vanishing Treatment

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 or 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 or dyed fabrics, including carpet and clothing which may be bleached by this product
• With other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
• Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if skin or eye irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Cleanse the skin thoroughly before applying medication
• 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 use a sunscreen. Allow Clearasil ULTRA® Rapid Action Vanishing Treatment Cream to dry, then follow directions on sunscreen labeling. If irritation or sensitivity develops, discontinue use of both products and ask a doctor

Other information

• Keep tightly closed
• Store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

Water, Gluconolactone, Glyceryl Stearate, Glycerin, PEG-40 Stearate, PEG-100 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Phenoxyethanol, Ammonium Hydroxide, Isopropylparaben, Butylparaben, Isobutylparaben, Arginine, Titanium Dioxide.

Questions?

Call 1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

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

Made in USA © RB 2011

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

ULTRA®

Rapid Action
Vanishing
Treatment
Cream

Benzoyl Peroxide 10%
Acne Medication

4
HOURS

Visibly
reduces
pimple size
and redness
in as little
as 4 hours

With Acceladerm®
Technology

1 FL. OZ. (28 g)

CLEARASIL   ULTRA RAPID ACTION VANISHING TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-309
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)
Gluconolactone (UNII: WQ29KQ9POT)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycerin (UNII: PDC6A3C0OX)
PEG-40 Stearate (UNII: ECU18C66Q7)
PEG-100 Stearate (UNII: YD01N1999R)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Xanthan Gum (UNII: TTV12P4NEE)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ammonia (UNII: 5138Q19F1X)
Isopropylparaben (UNII: A6EOX47QK0)
Butylparaben (UNII: 3QPI1U3FV8)
Isobutylparaben (UNII: 0QQJ25X58G)
Arginine (UNII: 94ZLA3W45F)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-309-01	1 in 1 CARTON	07/30/2011	09/02/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63824-309-02	1 in 1 CARTON	07/30/2011	09/02/2019
2		13 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	07/30/2011	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: e5b97929-6610-4ca1-af2a-ee52eace096e

34390-5

Set id: b3a45590-e275-4664-ae7e-d327d2056a43

Version: 3

Effective Time: 20190926