Label: CLEARASIL ULTRA ACNE PLUS MARKS DAILY SCRUB- salicylic acid lotion

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

Drug Label Information

Updated October 5, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    2% Salicylic acid

  • 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 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 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

    • for best results, use twice daily
    • wet face
    • dispense product into hands, lather and massage over face and neck avoiding eyes
    • rinse thoroughly in warm water and gently 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
  • Other information

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

    water, sodium cocoyl isethionate, glycerin, cetyl alcohol, laureth-3, polyethylene, sodium laureth sulfate, sodium cocoamphoacetate, niacinamide, sodium lactate, sorbitol, hexyldecanol, fragrance, acrylates C10-30 alkyl acrylate crosspolymer, sodium hydroxide, dipotassium glycrrhizate, disodium EDTA, bisabolol, cetylhydroxyproline palmitamide, stearic acid, polyquaternium-43, brassica campestris (rapeseed) sterols, phenoxyethanol, methylparaben, butylparaben, ethylparaben, isobutylparaben, propylparaben, FD&C blue no. 1, FD&C yellow no. 6

  • Questions?

    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 - 150 mL Tube Label

    NEW

    Clearasil®

    ULTRA

    Acne + Marks
    Daily Scrub

    Salicylic Acid 2% Acne Medication

    REDUCES
    MARKS

    Helps clear
    pimples fast,
    and reduces the
    appearance of
    acne marks

    5.0 FL OZ (150 mL)

    Principal Display Panel - 150 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA  ACNE PLUS MARKS DAILY SCRUB
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-395
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITOL (UNII: 506T60A25R)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-395-65150 mL in 1 TUBE; Type 0: Not a Combination Product05/04/201209/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00605/04/201209/01/2024
    Labeler - RB Health (US) LLC (081049410)