CLEARASIL ULTRA ACNE SYSTEM- salicylic acid and benzoyl peroxide   
Reckitt Benckiser 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.

----------

Clearasil®
Ultra Acne Solution System

Step 1: StayClear® Daily Face Wash

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

  • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
  • 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.
  • 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

Other information

Inactive ingredients

water, PPG-15 stearyl ether, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium chloride, sodium lauryl sulfate, oxidized polyethylene, cetyl alcohol, alcohol denat., steareth-21, sodium chloride, behenyl alcohol, PPG-30, steareth-2, fragrance, menthol, disodium EDTA, BHT

Step 2: StayClear® Daily Toner

Warnings

For external use only. Avoid contact with eyes and mouth. If in eyes, rinse eyes thoroughly with water. If ingested, rinse mouth thoroughly and drink a glass of water.

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

Keep out of reach of children.

Directions

Use everyday in the morning and evening after Step 1. Moisten a cotton ball and smooth over cleansed face and neck, avoiding eye area. Do not rinse. Allow product to dry completely. Follow with application of Step 3.

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: StayClear® Daily Lotion

Drug Facts

Active ingredient

Salicylic acid 0.5%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

  • avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
  • 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.

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

Other information

Inactive ingredients

water, glyceryl polymethacrylate, isohexadecane, cyclomethicone, glycerin, butylene glycol, PEG-8, steareth-2, lauryl methacrylate/glycol dimethacrylate crosspolymer, propylene glycol, polyacrylamide, steareth-21, C13-14 isoparaffin, xanthan gum, laureth-7, fragrance, sodium hydroxide, tetrasodium EDTA, methylparaben, propylparaben

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 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 eyes, lips, and mouth
  • avoid contact with hair or 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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Other information

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, arginine, isobutylparaben, butylparaben, titanium dioxide

Questions? Comments?

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

StayClear® Daily Face Wash made in France
StayClear® Daily Toner made in France
StayClear® Daily Lotion made in USA
Rapid Action Treatement Cream made in USA

PRINCIPAL DISPLAY PANEL - Kit Carton

Clearasil®

ULTRA

Acne Solution System

Up to
100% fewer
breakouts

in as little
as 4 weeks

1 Step 1
StayClear® Daily Face Wash
Salicylic Acid 2% Acne Medication
5 FL OZ (150 mL)

2 Step 2
StayClear® Daily Toner

5 FL OZ (150 mL)

3 Step 3
StayClear® Daily Lotion
Salicylic Acid 0.5% Acne Medication
1.5 FL OZ (45 mL)

Also includes:
Rapid Action Treatment Cream
Benzoyl Peroxide 10% Acne Medication
NET WT 0.45 OZ (13 g)

PRINCIPAL DISPLAY PANEL - Kit Carton
CLEARASIL  ULTRA ACNE SYSTEM
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-362
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-362-001 in 1 CARTON
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 STAYCLEAR DAILY FACE WASH
salicylic acid lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
PPG-15 stearyl ether 
glycerin 
stearyl alcohol 
cetyl betaine 
distearyldimonium chloride 
sodium lauryl sulfate 
cetyl alcohol 
steareth-21 
sodium chloride 
docosanol 
steareth-2 
menthol 
edetate disodium 
butylated hydroxytoluene 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2012
Part 2 of 4
CLEARASIL  ULTRA STAYCLEAR DAILY TONER
other skin care preparations solution
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRwater 
INGRaloe vera leaf 
INGRtetradonium bromide 
INGRceteareth-12 
INGRdisodium cocoamphodiacetate 
INGRsodium chloride 
INGRallantoin 
INGRchlorhexidine gluconate 
INGRtartaric acid 
INGRimidurea 
INGRmethylparaben 
INGRpropylparaben 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/01/2012
Part 3 of 4
CLEARASIL  ULTRA STAYCLEAR DAILY
salicylic acid lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
isohexadecane 
cyclomethicone 
glycerin 
butylene glycol 
polyethylene glycol 400 
steareth-2 
lauryl methacrylate/glycol dimethacrylate crosspolymer 
propylene glycol 
steareth-21 
C13-14 isoparaffin 
xanthan gum 
laureth-7 
sodium hydroxide 
edetate disodium 
methylparaben 
propylparaben 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
145 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2012
Part 4 of 4
CLEARASIL  ULTRA RAPID ACTION VANISHING TREATMENT
benzoyl peroxide cream
Product Information
Item Code (Source)NDC:63824-309
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water 
gluconolactone 
glyceryl monostearate 
glycerin 
PEG-40 stearate 
PEG-100 stearate 
cetyl alcohol 
dimethicone 
magnesium aluminum silicate 
xanthan gum 
phenoxyethanol 
ammonia 
isopropylparaben 
arginine 
isobutylparaben 
butylparaben 
titanium dioxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-309-0213 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2012
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 11/2012
Document Id: eaf06162-705f-4f85-84ba-a0558e4d3989
Set id: 1b4ec212-0b3c-4617-a8db-ecb3b7e46223
Version: 1
Effective Time: 20121128
 
Reckitt Benckiser LLC