Label: CLEARASIL ULTRA ACNE SYSTEM- salicylic acid and benzoyl peroxide   

  • Label RSS
  • NDC Code(s): 63824-309-02, 63824-362-00
  • Packager: Reckitt Benckiser LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Step 1: StayClear® Daily Face Wash

    Drug Facts

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  • Active ingredient

    Salicylic acid 2%

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  • Purpose

    Acne medication

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  • Use

    for the treatment of acne

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  • 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

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  • Directions

    • for best results, use twice daily. Use everyday 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
    • 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 directed by a doctor
    • if bothersome dryness or peeling occurs, reduce the application to once a day or every other day
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  • Other information

    • store in a cool, dry place
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  • 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

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  • SPL UNCLASSIFIED SECTION

    Step 2: StayClear® Daily Toner

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  • 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.

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  • 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.

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  • 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

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  • SPL UNCLASSIFIED SECTION

    Step 3: StayClear® Daily Lotion

    Drug Facts

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  • Active ingredient

    Salicylic acid 0.5%

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  • Purpose

    Acne medication

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  • Use

    for the treatment of acne

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  • 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

    Close
  • 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
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  • Other information

    • store in a cool, dry place
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  • 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

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  • SPL UNCLASSIFIED SECTION

    Rapid Action Treatment Cream

    Drug Facts

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  • Active ingredient

    Benzoyl peroxide 10%

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  • Purpose

    Acne medication

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  • Use

    for the treatment of acne

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  • 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.

    Close
  • Directions

    • clean skin thoroughly before applying this product
    • cover the entire effected area with a thin layer, one to three times 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 as a doctor.
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  • Other information

    • keep tightly closed
    • store at controlled room temperature 68-77°F (20-25°C)
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  • 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

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  • Questions? Comments?

    Call 1-866-25-CLEAR (1-866-252-5327) You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

    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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    CLEARASIL  ULTRA ACNE SYSTEM
    salicylic acid and benzoyl peroxide kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-362
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-362-00 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, PUMP 150 mL
    Part 2 1 BOTTLE 150 mL
    Part 3 1 TUBE 45 mL
    Part 4 1 TUBE 13 g
    Part 1 of 4
    CLEARASIL  ULTRA STAYCLEAR DAILY FACE WASH
    salicylic acid lotion
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 2 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2012
    Part 2 of 4
    CLEARASIL  ULTRA STAYCLEAR DAILY TONER
    other skin care preparations solution
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR water  
    INGR aloe vera leaf  
    INGR tetradonium bromide  
    INGR ceteareth-12  
    INGR disodium cocoamphodiacetate  
    INGR sodium chloride  
    INGR allantoin  
    INGR chlorhexidine gluconate  
    INGR tartaric acid  
    INGR imidurea  
    INGR methylparaben  
    INGR propylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 150 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    COSMETIC 01/01/2012
    Part 3 of 4
    CLEARASIL  ULTRA STAYCLEAR DAILY
    salicylic acid lotion
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 45 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2012
    Part 4 of 4
    CLEARASIL  ULTRA RAPID ACTION VANISHING TREATMENT
    benzoyl peroxide cream
    Product Information
    Item Code (Source) NDC:63824-309
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-309-02 13 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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