Label: DAILY CLEANSING- salicylic acid swab

  • 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 December 28, 2009

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  • ACTIVE INGREDIENT

    Salicylic acid 2.0% w/w
  • PURPOSE

    Acne medication
  • USE

    for the treatment of acne
  • WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    Allergy alert

    do not use this product if you have a known allergy to salicylic acid.



    When using this product

    use of other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.




    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Cleanse the skin thoroughly before applying medication
    • Use the pad to wipe the entire affected area one to three times daily
    • Repeat with a clean pad as necessary to remove remaining traces of dirt
    • 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 of peeling occurs, reduce application to once a day or every other day
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    • KEEP TIGHTLY CLOSED
    • Store at room temperature: 15°- 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS

    alcohol, disodium EDTA, fragrance, isoceteth-20, polyolprepolymer-15, purified water, triethalnolamine
  • QUESTIONS


  • LABEL INFORMATION - REPRESENTATIVE LABEL

    Compare to the active ingredient in Oxy®*

    Daily Cleansing Pads

    2% Salicylic Acid acne medication

    Aggressively treats and helps prevent pimples

    MAXIMUM STRENGTH
    90 PADS


    *This product is not manufactured or distributed by The Mentholatum Co. Inc., owner of the registered trademark, OXY®.

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  • INGREDIENTS AND APPEARANCE
    DAILY CLEANSING 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-7801-290 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/31/2003
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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