Label: CLEARASIL ULTRA ACNE PLUS MARKS SPOT- salicylic acid lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • SPL UNCLASSIFIED SECTION

    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, lips and mouth. If contact occurs, 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
    • Wash hands after use
    • Sun Alert:Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use

    Stop use and ask a doctor ifskin or eye irritation develops.

    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

    • Keep tightly closed
    • Store at 20-25°C (68-77°F)
  • Inactive ingredients

    Water, Alcohol Denat., Octyldodecanol, Dimethicone, Niacinamide, Sodium Lactate, Isohexadecane, Polyacrylamide, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Hexyldecanol, C13-14 Isoparaffin, Magnesium Aluminum Silicate, Fragrance, Laureth-7, Disodium EDTA, Dipotassium Glycyrrhizate, Bisabolol, Cetylhydroxyproline Palmitamide, Stearic Acid, Brassica Campestris (Rapeseed) Sterols, Titanium Dioxide

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

    Clearasil ®

    ULTRA

    Acne + Marks
    Spot Lotion
    Salicylic Acid 2% Acne Medication

    REDUCES
    MARKS

    Helps to clear
    pimples fast
    and reduce the
    appearance of
    acne marks

    1 FL. OZ. (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA  ACNE PLUS MARKS SPOT
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-347
    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)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-347-011 in 1 CARTON08/01/201109/01/2024
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/01/201109/01/2024
    Labeler - RB Health (US) LLC (081049410)
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