Label: 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

Drug Label Information

Updated September 6, 2019

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

  • ACTIVE INGREDIENT

     Active Ingredient Purpose
    Chlorhexidine Gluconate 2% Solution    Antiseptic

  • PURPOSE

  • Uses

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

    For external use only

    Allergy alert:

    This product may cause a severe allergic reaction. Symptoms may include:

    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use

    • on patients allergic to chlorhexidine gluconate or any other ingredient 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.

  • Keep out of reach of children

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

  • 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 cm 2 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 cm 2 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

    Other information

    • store product flat
    • store between 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

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

    cloth:  polyester

  • Questions or comments?

    call toll-free 800-323-2220

    (Monday to Friday 8 AM - 5 PM CST)

    www.sageproducts.com

  • Chlorhexidine Gluconate 2% Solution - 9705

    9705 Inner Carton Label9705 Primary Package Label

  • Chlorhexidine Gluconate 2% Solution - 9707

    9707 Inner Carton Label9707 Primary Package Label

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-705-202 in 1 PACKAGE; Type 0: Not a Combination Product02/01/2006
    2NDC:53462-705-236 in 1 PACKAGE; Type 0: Not a Combination Product02/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02166902/01/2006
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)