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

----------

Clearasil ®
Ultra Rapid Action Treatment Cream

Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

Do not useif 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 ifskin 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 ClearasilULTRA ®Rapid Action Treatment Cream to dry, apply sunscreen after using this product.
    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, benzyl alcohol, ammonium hydroxide, arginine, benzoic acid, sorbic acid, 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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil ®

ULTRA

Rapid
Action
Treatment
Cream

Benzoyl Peroxide 10%
Acne Medication

4
HRS
MAXIMUM STRENGTH

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

Paraben-free

NET WT.: 1 OZ. (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
CLEARASIL  ULTRA RAPID ACTION TREATMENT
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-424
Route of AdministrationTOPICAL
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)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
AMMONIA (UNII: 5138Q19F1X)  
ARGININE (UNII: 94ZLA3W45F)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-424-011 in 1 CARTON06/15/201609/01/2020
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63824-424-021 in 1 CARTON06/15/201609/01/2020
212 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00606/15/201609/01/2020
Labeler - RB Health (US) LLC (081049410)

Revised: 10/2023
Document Id: 06fd70ae-8e25-90b7-e063-6294a90a0622
Set id: 3dbc79f6-9685-4163-a9e6-ead0e675bac1
Version: 2
Effective Time: 20231005
 
RB Health (US) LLC