Label: CLEARASIL RAPID RESCUE SPOT TREATMENT- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 24, 2022

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  • SPL UNCLASSIFIED SECTION

    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 the eyes, lips and mouth
    • avoid contact with hair and dyed fabrics, including carpet and clothing, 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 immediately.

  • 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

    • keep outer box for full product information
    • keep tightly closed
    • store at controlled room temperature 68-77 °F (20-25 °C)
  • Inactive ingredients

    Water, Gluconolactone, Glyceryl Stearate, PEG-40 Stearate, Glycerin, PEG-100 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Benzyl Alcohol, Ammonium Hydroxide, Arginine, Benzoic Acid, Sorbic Acid, Titanium Dioxide

  • Questions?

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

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RB Health (US),
    Parsippany, NJ
    07054-0224

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Clearasil®

    RAPID RESCUE
    SPOT TREATMENT
    CREAM

    Benzoyl Peroxide
    Acne Medication

    VISIBLE
    RESULTS
    AS FAST AS
    4 HOURS

    MAXIMUM
    STRENGTH

    STARTS TO WORK
    INSTANTLY

    Net wt. 1 oz (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLEARASIL RAPID RESCUE SPOT TREATMENT 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-433
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    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:63824-433-011 in 1 CARTON12/06/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/06/2017
    Labeler - RB Health (US) LLC (081049410)
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