CLEARASIL  ULTRA TINTED RAPID ACTION TREATMENT- benzoyl peroxide cream 
Reckitt Benckiser, 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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Clearasil
ULTRA®

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 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 ® Tinted Rapid Action Treatment Cream to dry, then follow directions in 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, Propylene Glycol, PEG 100 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Phenoxyethanol, Ammonium Hydroxide, Isopropyl Paraben, Arginine, Isobutyl Paraben, Butyl Paraben, Iron Oxides, Titanium Dioxide

Questions? Comments?

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

For details call the number above or
visit us at www.clearasil.com

Distributed by: Reckit Benckiser Inc Parsippany,
NJ 07054-0224.

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Dermatologically
Tested

Clearasil
ULTRA ®

Tinted

Rapid Action™
Treatment
Cream

Acceladerm™
Technology

4
HOURS

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

Actual Size

10% BENZOYL PEROXIDE
ACNE MEDICATION

NET WT.: 1 OZ. (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
CLEARASIL   ULTRA TINTED RAPID ACTION TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-310
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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)  
ARGININE (UNII: 94ZLA3W45F)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-310-011 in 1 CARTON08/04/200904/04/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/04/200904/04/2016
Labeler - Reckitt Benckiser, Inc. (094405024)

Revised: 4/2016
 
Reckitt Benckiser, Inc.