Label: ASEPXIA FACIAL CLEANSING- salicylic acid cloth

  • 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 January 11, 2011

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  • Drug Facts

    Active ingredient                         Purpose

    Salicylic acid 0.5%................ Acne Treatment

  • Uses

    Enter section text here

  • INDICATIONS & USAGE

    • for the treatment of acne
  • Warnings

    For external use only

    When using this product

    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.

    Keep out of the reach of children.

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

  • Directions

    Clean the skin thoroughly before applying this product.

    • cover the entire affected area with a thin layer one to three times daily.
    • 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 both some dryness or peeling occurs, reduce application to once a day or every other day.
    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • Other information

    Store in a cool dry place. Keep outer packaging for precautions and directions

  • Inactive ingredients

    water, alcohol denatured (20% vlv), hamamelis virginiana (witch hazel) extracts, polysorobate 20, propylene glycol, sodium citrate, fragrance, panthenol, Disodium EDTA, chamomila recutita (matricaria) flower extract, 2-bomo-2-nitropropane-1-3-diol, iodopropynyl butylcarbamate, glycolic acid.

  • Questions or comments?

    1 877 99 GENOM (4366)

  • PRINCIPAL DISPLAY PANEL

    (front of packet)

    Remove oil and dirt

    For the treatment of Acne

    Content: 10 Wipes

    (back of packet)

    Made in Israel

    Distributed by

    Televisa Consumer Products

    USA, LLC 4550 Post Oak Place

    Suite 326 Houston, TX 77027

    Lot No

    Exp.:

    Packet Label - Front & Back

  • INGREDIENTS AND APPEARANCE
    ASEPXIA  FACIAL CLEANSING
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CHAMOMILE (UNII: FGL3685T2X)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-410-1053 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/30/2011
    Labeler - Fischer Pharmaceuticals Ltd. (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd.600158976manufacture
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