Label: CLEARASIL ULTRA DAILY FACE WASH- salicylic acid solution

  • 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 July 19, 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 the eyes. 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

    Stop use and ask 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

    • Wet face
    • Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area.
    • Rinse thoroughly with warm water and pat dry.
    • For best results, use twice daily
  • Other information

    • keep tightly closed
    • store in a cool dry place.
  • Inactive ingredients

    Water, Sodium Cocoyl Isethionate, Cetearyl Alcohol, Laureth-3, Glycerin, Coconut Acid, Sodium Isethionate, Sodium Hydroxide, Fragrance, Lavandula Stoechas Extract, Helchrysum Italicum Extract, Cistus Monspeliensis Extract, Disodium EDTA, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.

  • SPL UNCLASSIFIED SECTION

    For best before date see tube seal.

    www.clearasil.com

  • Questions? Comments?

    Call 1-866-25-CLEAR
    (1-866-252-5327)*

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reckitt Benckiser Inc.
    Parsippany, NJ 07054-0224
    Made in USA © RBI 2009

  • PRINCIPAL DISPLAY PANEL - 200 mL Label

    Dermatologist
    Tested

    Clearasil
    Ultra ®

    NEW
    FORMULA

    Daily Face
    Wash

    100%

    Fights 100% of acne

    2% SALICYLIC ACID ACNE MEDICATION
    6.78 FL. OZ. (200 mL)

    Principal Display Panel - 200 mL Label
  • INGREDIENTS AND APPEARANCE
    CLEARASIL ULTRA  DAILY FACE WASH
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-315
    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 COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-315-011 in 1 CARTON08/20/200909/01/2024
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/20/200909/01/2024
    Labeler - RB Health (US) LLC (081049410)
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