Clearasil® Ultra® Fast Fix Acne Kit

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL ULTRA  FAST FIX ACNE- 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®
Fast Fix Acne Kit

Step 1: Clearasil Ultra Acne Cleansing 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 the eyes. If product gets into the 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

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

Directions

  • use everyday in the morning and evening
  • wet face
  • dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
  • cover the entire affected area with a thin layer and rinse thoroughly with warm water 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

Other information

  • store at 20-25°C (68-77°F)

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: Clearasil Ultra Reviving Toner

Caution

For external use only. Avoid contact with eyes or mouth. If product gets into the eyes or in mouth rinse thoroughly with water. Stop use if skin irritation occurs. May not be suitable for 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 the eyes. 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: Clearasil Ultra Daily Lotion

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 the eyes. If product gets into the 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.

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

Directions

  • clean the skin thoroughly before applying this product
  • 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

Other information

  • store at 20-25°C (68-77°F)

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, phenoxyethanol, fragrance, sodium hydroxide, tetrasodium EDTA

CLEARASIL Ultra Rapid Action Treatment Cream

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Uses

  • for the treatment of acne
  • helps prevent new acne pimples from forming

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 the eyes, lips and mouth
  • avoid contact with hair and 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.
If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • clean the skin thoroughly before applying this product
  • 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

  • store at 20-25°C (68-77°F)

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

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

Clearasil Ultra Acne Cleansing Wash made in France
Clearasil Ultra Reviving Toner made in France

PRINCIPAL DISPLAY PANEL - Kit Carton

VISIBLE
RESULTS
IN AS FAST AS
4 HRS

Clearasil®

ULTRA®

Fast Fix
Acne Kit

Up to 100%
fewer breakouts
in as little as
4 weeks

Also includes:
Rapid Action
Treatment Cream

Benzoyl Peroxide 10% Acne Medication
NET WT 0.45 OZ (13 g)

1

Acne Cleansing Wash
Salicylic Acid 2% Acne Medication
5 FL OZ (150 mL)

2

Reviving Toner
5 FL OZ (150 mL)

3

Hydrating Lotion
Salicylic Acid 0.5% Acne Medication
1.5 FL OZ (45 mL)

Principal Display Panel - Kit Carton
CLEARASIL ULTRA   FAST FIX ACNE
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-414
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-414-001 in 1 CARTON11/01/201309/02/2019
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   ACNE CLEANSING WASH
salicylic acid lotion
Product Information
Item Code (Source)NDC: 63824-308
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)  
steareth-21 (UNII: 53J3F32P58)  
sodium chloride (UNII: 451W47IQ8X)  
docosanol (UNII: 9G1OE216XY)  
PPG-30 (UNII: H5B6JCZ906)  
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
1NDC: 63824-308-65150 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/01/201309/02/2019
Part 2 of 4
CLEARASIL ULTRA   REVIVING 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 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC11/01/201309/02/2019
Part 3 of 4
CLEARASIL ULTRA   HYDRATING
salicylic acid lotion
Product Information
Item Code (Source)NDC: 63824-311
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)  
phenoxyethanol (UNII: HIE492ZZ3T)  
sodium hydroxide (UNII: 55X04QC32I)  
edetate sodium (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-311-4545 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/01/201309/02/2019
Part 4 of 4
CLEARASIL ULTRA   RAPID ACTION TREATMENT
benzoyl peroxide cream
Product Information
Item Code (Source)NDC: 63824-312
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)  
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: 63824-312-0213 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/01/201309/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/01/201309/02/2019
Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019
 

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