Label: CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate cloth

  • NDC Code(s): 53462-705-20, 53462-705-23
  • Packager: Sage Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

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 10/14

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

  • ACTIVE INGREDIENT

    chlorhexidine gluconate 2% solution

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  • PURPOSE

    Antiseptic

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    • helps reduce bacteria that can potentially cause skin infection
    • for preparation of skin prior to surgery
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  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product
    • for lumbar punctures or in contact with the meninges
    • on open skin wounds or as a general skin cleanser

    When using this product

    • keep out of eyes, ears, and mouth.  May cause serious or permanent injury if chlorhexidine is permitted to enter and remain.  If contact occurs, rinse with cold water right away and contact a doctor.

    Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.  These may be signs of a serious condition.

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • use with care in premature infants or infants under 2 months of age.  These products may cause irritation or chemical burns.
    • do not microwave
    • product and packaging are not sterile.  Follow your hospital policy for skin preparation with non-sterile products.

    To open package

    • holding top of package in one hand, lift flap on backside of package with other hand
    • grasp flap at top and pull down to tear flap away and expose foam
    • hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.

    Or

    • using sterile scissors, cut off end seal of package
    • transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
    • use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated.  Use second cloth to prepare larger areas.
    • dry surgical sites (such as abdomen or arm):  use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
    • moist surgical sites (such as inguinal fold):  use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared.  Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute.  Do not rinse.
    • discard each cloth after a single use
    • after package has been opened discard any unused cloths
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  • INACTIVE INGREDIENT

    aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water

    cloth:  polyester

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  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate cloth
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53462-705
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chlorhexidine gluconate (chlorhexidine) chlorhexidine gluconate 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    water  
    nonoxynol-9  
    polysorbate 20  
    dimethicone 350  
    propylene glycol  
    aloe vera leaf  
    glycerin  
    gluconolactone  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53462-705-20 2 in 1 PACKAGE; Combination Product Type = C112160
    2 NDC:53462-705-23 6 in 1 PACKAGE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021669 02/01/2006
    Labeler - Sage Products LLC (054326178)
    Establishment
    Name Address ID/FEI Business Operations
    Sage Products, Inc. 054326178 MANUFACTURE(53462-705)
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