CLEARASIL  ULTRA RAPID ACTION ACNE SYSTEM- salicylic acid and benzoyl peroxide 
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 Acne Solution System

Step 1: Ultra® Rapid Action Daily Face Wash

Drug Facts

Active ingredient

Salicylic acid 2.0%

Purpose

Acne medication

Use

  • for daily facial cleansing.
  • for the treatment and prevention of acne.

Warnings

For external use only

When using this product

  • avoid contact with eyes. If product gets into the eyes rinse thoroughly with water.
  • 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 acne medication should be used unless directed by your doctor.
  • limit use to the face and neck.

Stop use and ask a doctor if skin or eye irritation develops.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • use every day in the morning and evening.
  • wet face.
  • dispense 1 pump of wash into palm of hand.
  • add water and gently massage onto face, avoiding eye area.
  • rinse off thoroughly with warm water and pat dry.
  • wash hands after use.

Other information

  • store in a cool dry place.

Inactive ingredients

Water, PPG-15 Stearyl Ether, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Oxidized Polyethylene, Cetyl Alcohol, Alcohol, Steareth-21, Sodium Chloride, Behenyl Alcohol, PPG-30, Steareth-2, Fragrance, Menthol, Disodium EDTA, BHT.

Step 2: Ultra® Rapid Action Daily Toner

Warnings

Don't get this toner in your eyes or mouth. If you do, rinse it out with lots of water.

Stop using it if skin irritation occurs. This lotion may not suit very dry skin.

Keep out of reach of children.

Directions

Use every day in the morning and the evening after Step 1. Moisten a cottonball and smooth over cleansed face, avoiding eye area. Do not rinse. Allow product to dry.

Inactive ingredients

Water, Alcohol Denat., Aloe Barbadensis Leaf Juice, Myrtrimonium Bromide, Ceteareth-12, Disodium Cocoamphodiacetate, Sodium Chloride, Allantoin, Chlorhexidine Digluconate, Tartaric Acid, Imidazolidinyl Urea, Methylparaben, Propylparaben.

Step 3: Ultra® Rapid Action Daily Lotion

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Medication

Use

for the treatment and prevention of acne.

Warnings

For external use only

When using 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 your doctor.
  • avoid contact with the eyes. If product gets into eyes, rinse thoroughly with water.

Stop use and ask a doctor if skin or eye irritation develops.

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • use everyday in the morning and evening after Step 2.
  • cleanse the skin thoroughly before applying medication.
  • cover the entire affected area with a thin layer one to three times a day.
  • 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.
  • wash hands after use.

Other information

store in a cool dry place.

Inactive ingredients

Water, Glycerin, Isohexadecane, Butylene Glycol, Steareth-2, PEG-8, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Cyclohexasiloxane, Polyacrylamide, Steareth-21, C13-14 Isoparaffin, Xanthan Gum, Laureth-7, Glyceryl Acrylate/Acrylic Acid Copolymer, Propylene Glycol, Fragrance, Sodium Hydroxide, Tetrasodium EDTA, Methylparaben, Propylparaben.

Ultra® Rapid Action Treatment Cream

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Use

for the treatment and prevention of acne pimples.

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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • follow Step 3 evening application by applying a thin layer to your acne pimples. Because excessive drying may occur, start with nightly application for the first 3 nights then reduce application to as needed.
  • if going outside, use a sunscreen. Allow Clearasil Ultra® Rapid Action Treatment Cream to dry, then follow directions in sunscreen labeling. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Other information

  • keep tightly closed.
  • keep away from heat.

Inactive ingredients

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

Questions? Comments?

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

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

Ultra® Rapid Action Daily Face Wash made in France
Ultra® Rapid Action Daily Toner made in France
Ultra® Rapid Action Daily Lotion made in USA
Ultra® Rapid Action Treatment Cream made in USA

PRINCIPAL DISPLAY PANEL - Kit Carton

Rapid Action
Acne Solution System

Clearasil®
ULTRA®

VISIBLY CLEARER SKIN
IN AS LITTLE AS*
4
HOURS

BONUS

*Ultra® Rapid Action Treatment Cream
0.45 OZ. (13 g)

Ultra® Rapid Action Daily Face Wash
5 FL. OZ. (150 mL)

Ultra® Rapid Action Daily Toner
5 FL. OZ. (150 mL)

Ultra® Rapid Action Daily Lotion
1.5 FL. OZ. (45 mL)

PRINCIPAL DISPLAY PANEL - Kit Carton
CLEARASIL  ULTRA RAPID ACTION ACNE SYSTEM
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-354
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-354-001 in 1 CARTON01/01/201109/02/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 150 mL
Part 21 BOTTLE 150 mL
Part 31 TUBE 45 mL
Part 41 TUBE 13 g
Part 1 of 4
CLEARASIL   ULTRA RAPID ACTION DAILY FACE WASH
salicylic acid lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PPG-15 Stearyl Ether (UNII: 1II18XLS1L)  
Glycerin (UNII: PDC6A3C0OX)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Cetyl Betaine (UNII: E945X08YA9)  
Distearyldimonium Chloride (UNII: OM9573ZX3X)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Alcohol (UNII: 3K9958V90M)  
Steareth-21 (UNII: 53J3F32P58)  
Sodium Chloride (UNII: 451W47IQ8X)  
Docosanol (UNII: 9G1OE216XY)  
Steareth-2 (UNII: V56DFE46J5)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Edetate Disodium (UNII: 7FLD91C86K)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201109/02/2019
Part 2 of 4
CLEARASIL   ULTRA RAPID ACTION DAILY TONER
other skin care preparations solution
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWater (UNII: 059QF0KO0R)  
INGRAloe Vera Leaf (UNII: ZY81Z83H0X)  
INGRTetradonium Bromide (UNII: 8483H94W1E)  
INGRCeteareth-12 (UNII: 7V4MR24V5P)  
INGRDisodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
INGRSodium Chloride (UNII: 451W47IQ8X)  
INGRAllantoin (UNII: 344S277G0Z)  
INGRChlorhexidine Gluconate (UNII: MOR84MUD8E)  
INGRTartaric Acid (UNII: W4888I119H)  
INGRImidurea (UNII: M629807ATL)  
INGRMethylparaben (UNII: A2I8C7HI9T)  
INGRPropylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/201109/02/2019
Part 3 of 4
CLEARASIL   ULTRA RAPID ACTION DAILY
salicylic acid lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Isohexadecane (UNII: 918X1OUF1E)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Steareth-2 (UNII: V56DFE46J5)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer (UNII: EX0F4CZ66H)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Steareth-21 (UNII: 53J3F32P58)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Xanthan Gum (UNII: TTV12P4NEE)  
Laureth-7 (UNII: Z95S6G8201)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Edetate Sodium (UNII: MP1J8420LU)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
145 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201109/02/2019
Part 4 of 4
CLEARASIL   ULTRA RAPID ACTION VANISHING TREATMENT
benzoyl peroxide cream
Product Information
Item Code (Source)NDC:63824-309
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-309-0213 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201109/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/201109/02/2019
Labeler - RB Health (US) LLC (081049410)

Revised: 8/2019
 
RB Health (US) LLC