Label: CLEARASIL ULTRA RAPID ACTION SEAL-TO-CLEAR- salicylic acid gel

  • 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

    Flammable

    keep away from open fire or flame

    When using this product

    • Avoid contact with the eyes, lips and mouth. If product gets into the eyes, rinse thoroughly with water
    • With other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by your doctor
    • Limit use to the face and neck
    • Wash hands after use

    Stop use and ask a doctor ifskin 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

    • Cleanse the skin thoroughly, as needed, before applying medication
    • Cover the affected area with a thin layer one to three times a day and allow to 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 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 in a cool, dry place
    • Cap may pose choking hazard
  • Inactive ingredients

    Water, Alcohol Denat., Sodium Gluconate, Propylene Glycol, Hydroxyethylcellulose, Isoceteth-20, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Sodium Benzoate, Oryza Sativa (Rice) Extract.

  • 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

  • PRINCIPAL DISPLAY PANEL - 12 mL Tube Label

    Clearasil ®

    ULTRA ®

    Rapid Action
    Seal-to-Clear ®Gel
    Salicylic Acid 2% Acne Medication

    4
    HOURS

    Seals your
    pimple and
    visibly reduces
    its size and
    redness in
    4 hours

    With Invisa Skin ®

    0.42 FL. OZ. (12 mL)

    Principal Display Panel - 12 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA  RAPID ACTION SEAL-TO-CLEAR
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-353
    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)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    RICE OIL (UNII: ACU8G2V809)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-353-011 in 1 CONTAINER07/21/201109/01/2024
    112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/21/201109/01/2024
    Labeler - RB Health (US) LLC (081049410)
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