READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%) CLOTH [MEDLINE INDUSTRIES]

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READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%) CLOTH [MEDLINE INDUSTRIES]
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NDC 53329-244-01, 53329-244-02
Set ID 458cf999-5e3d-4d4d-82d5-02118c331893
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number NDA207964
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  • ACTIVE INGREDIENT

    Chlorhexidine gluconate 2% solution

  • PURPOSE

    Antiseptic

  • Uses

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

    For external use only

    • 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
    • as a general skin cleanser

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

    • 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.

    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.

    If swallowed, get medical help or contact a Posion 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: identify the tear notch labeled on the front of the package. Grasp with both hands on both sides of the tear notch and tear to expose cloth.
    • transfer contents onto prep table, avoiding contact between cloth 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 seconfdcloth 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 discaard. Allow area to 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, competely wetting treatment area, then discard. Allow area to 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 degrees Celsius (68-77 degrees Fahrenheit)
    • avoid excessive heat above 40 degrees Celsius (104 degrees Fahrenheit)
  • INACTIVE INGREDIENT

    • benzalkonium chloride
    • dimethicone emulsion
    • glycerin
    • isopropyl alcohol
    • propylene glycol
    • purified water USP
  • SPL UNCLASSIFIED SECTION

    DO NOT FLUSH

    Non-Sterile.

    Product is not made with Natural Rubber Latex.

    Cloth: 100% Polyester

    REF MSC095CHG

    www.medline.com

    ©2017 Medline Industries, Inc.

    Medline is a registered trademark of Medline Industries, Inc.

    Manufactured by

    Medline Industries, Inc.,

    Northfield, IL 60093 USA.

    Made in USA with domestic and foreign materials.

    Questions, comments, or ordering call: 1-800-MEDLINE

    Customer Service Hours:

    (Monday to Friday, 7 AM to 7 PM CST)

    RI17MSC

  • Pouch label

    READYPREPTM CHG

    CHLORHEXIDINE GLUCONATE 2%

    PATIENT PREOPERATIVE SKIN PREPARATION CLOTH 095 Pack

    NON-STERILE

    EQUIVALENT TO 500MG CHLORHEXIDINE GLUCONATE PER CLOTH

    Provides rapid bactericidal action against a broad spectrum of microorganisms
    Significantly reduces the number of microorganisms on intact skin
    Demonstrates continued antimicrobial activity for up to 6 hours after application

    FRAGRANCE FREE

    RINSE FREE

    SINGLE USE ONLY.

    FOR EXTERNAL USE ONLY.

    DO NOT MICROWAVE

    2 9 X 10.5 IN (22.9 X 26.7 CM) DISPOSABLE CLOTHS

    REF MSC095CHG

  • INGREDIENTS AND APPEARANCE
    READYPREP CHG 
    chlorhexidine gluconate 2% cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-244
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-244-0224 in 1 CARTON01/14/2019
    1NDC:53329-244-012 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20796401/14/2019
    Labeler - Medline Industries, LP (025460908)
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