Label: SERDAEN- chlorhexidine diacetate soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 13, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Chlorhexidine Diacetate 1%

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Cola Det SDC, Sodium Xylem Sulfate, Tocopheryl Acetate, Fragrance

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    Prevent overgrowth of bacteria prior to surgical procedure

    Prevent recurrent bacterial infections

    Prevent infections around superficial wounds

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help

    or contact a poison control center right away.

  • WARNINGS

    Warnings

    For external use only.

    Do not use:

    If allergic to Chlorhexidine or other ingredients in formulation

    In contact with the genital area

    On wounds that exceed the superficial layer of skin.

  • WHEN USING

    When using this product

    Avoid eye contact. Should contact occur,

    rinse thoroughly with water.

  • STOP USE

    Discontinue use and consult a health care practitioner

    if irritation or allergic reaction develops.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally to moistened area, wash and rinse thoroughly.

    All product should be rinsed and dried immediately

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SERDAEN  
    chlorhexidine diacetate soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56149-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE48 mg  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56149-002-023 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2013
    Labeler - Browne Hansen LLC (962275843)
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