Label: SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 22, 2012

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

  • ACTIVE INGREDIENT

    Active ingredient

    chlorhexidine gluconate 2% solution

    Povidone-Iodine USP, 5%

  • PURPOSE

    Purpose

    Antiseptic

  • 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.

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only

  • STOP USE

    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

    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.

    Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water.  Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

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

  • DOSAGE & ADMINISTRATION

    Directions

    2% Chlorhexidine Gluconate Cloth

    • 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

    Directions

    3M Skin and Nasal Antiseptic

    • open package and remove bottle and swabs
    • unscrew cap by turning cap counter-clockwise

    Skin Application:

    1. Apply to clean dry skin.
    2. Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
    3. Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
    4. Repeat steps 2 & 3 using second swab.
    5. Allow prep solution to dry. Do not blot.

    Nasal Application:

    1. Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
    2. Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
    3. Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
    4. Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
    5. Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
    6. Do not blow nose. If solution drips out of nose, it can be lightly dabbed with a tissue.
  • INACTIVE INGREDIENT

    Inactive ingredients

    2% Chlorhexidine Gluconate Cloth
    aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water

    cloth: polyester

    Inactive ingredients

    3M Skin and Nasal Antiseptic
    Lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol

  • PRINCIPAL DISPLAY PANEL

    2% Chlorhexidine Gluconate* Cloth
    NDC 053462–705–23

    2% chlorhexidine gluconate cloth
  • PRINCIPAL DISPLAY PANEL

    3M Skin and Nasal Antiseptic
    NDC 17518–060–04

    3M Skin and Nasal Antiseptic NDC 17518-060-04
  • PRINCIPAL DISPLAY PANEL

    3M Skin and Nasal Antiseptic
    NDC 17518–060–04

    NDC 17518–060–04
  • INGREDIENTS AND APPEARANCE
    SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS 
    chlorhexidine gluconate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-008
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-008-281 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE
    Part 21 BOTTLE 4 mL
    Part 1 of 2
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate cloth
    Product Information
    Item 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:53462-705-236 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02166902/01/2006
    Part 2 of 2
    3M SKIN AND NASAL ANTISEPTIC 
    3m skin and nasal antiseptic solution
    Product Information
    Item Code (Source)NDC:17518-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM IODIDE (UNII: F5WR8N145C)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH
    1NDC:17518-060-044 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02166902/06/2012
    Labeler - Sage Products, Inc. (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products, Inc.054326178MANUFACTURE(53462-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M ESPE Dental Products078404534MANUFACTURE(17518-060, 53462-705)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Health Care LTD218829455MANUFACTURE(17518-060, 53462-705)