Label: MEDICATED ACNE PADS- 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
  • USES

    • for the treatment and management of acne
    • reduces the number of acne pimples and blackheads and allows skin to heal
    • helps to prevent new acne pimples from forming
  • WARNINGS

    For external use only. Keep away from eyes, lips and other mucous membranes.

    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 and discard
    • Do not leave pad on skin for an extended period of time
    • 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

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

    ammonium laureth sulfate, ammonium xylenesulfonate, citric acid, disodium EDTA, DMDM hydantoin, fragrance, menthol, potassium carbonate, PPG-5-ceteth-20, purified water, simethicone
  • QUESTIONS


  • LABEL INFORMATION - REPRESENTATIVE LABEL

    MAXIMUM STRENGTH

    ACNE PADS

    MEDICATED WITH SALYCYLIC ACID

    • Clean, Treat and Prevent Acne Blemishes
    • Alcohol-free
    • Easy Lift Notch For Easy Removal From Jar
    55 PADS

    label

  • BOX INFORMATION - REPRESENTATIVE BOX

    MAXIMUM STRENGTH

    ACNE PADS

    MEDICATED WITH SALYCYLIC ACID

    • Clean, Treat and Prevent Acne Blemishes
    • Alcohol-free
    • Easy Lift Notch For Easy Removal From Jar


    Compare to STRI-DEX® active ingredients*

    55 PADS (2-1/8" diameter)


    *This product is not manufactured or distributed by Blistex, Inc., owner of the registered trademark STRIDEX®.

    box

  • INGREDIENTS AND APPEARANCE
    MEDICATED ACNE PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.02 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN (UNII: BYR0546TOW)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASH (UNII: BQN1B9B9HA)  
    CETETH-20 (UNII: I835H2IHHX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-7701-01 in 1 BOX
    155 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/02/2003
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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