Label: ASEPXIA  - salicylic acid lotion 

  • NDC Code(s): 55038-555-01
  • Packager: Televisa Consumer Products USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • Active Ingredients

    Salicylic Acid 1.86%

    Purpose

    Acne Treatment

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  • Uses

    • for the treatment of acne
    • clears up acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal
    • helps prevent new acne blemishes, acne pimples, blackheads or whiteheads from forming.
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  • 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 he 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.

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  • 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.
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  • Inactive Ingredients

    benzalkonium chloride, benzoic acid, camphor, clove oil, ethyl alcohol, eucalyptus oil, peppermint oil, water.

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  • Questions or Comments?

    1 877 99 GENOM  
                   (43666)

    Made in Mexico

    Distributed by:
    Televisa Consumer Products USA, LLC
    4550 Post Oak Place Suite 326
    Houston, TX 77027

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  • PRINCIPAL DISPLAY PANEL

    Asepxia

    Acne Lotion

    For the treatment of Acne

    Eliminates most pimples and blackheads

    Net Wt 4fl oz (120mL)

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  • Outer Container Label
  • Container Label
  • INGREDIENTS AND APPEARANCE
    ASEPXIA  
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55038-555
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 18.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BENZOIC ACID  
    CAMPHOR (SYNTHETIC)  
    CLOVE OIL  
    ALCOHOL  
    EUCALYPTUS OIL  
    PEPPERMINT OIL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55038-555-01 120 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/17/2011
    Labeler - Televisa Consumer Products USA (840246230)
    Registrant - Laboratorios Kener, S.A. de C.V. (810347658)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratorios Kener, S.A. de C.V. 810347658 manufacture(55038-555)
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