Label: READYPREP CHG- chlorhexidine gluconate 2% cloth
- NDC Code(s): 53329-244-01, 53329-244-02
- Packager: Medline Industries
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated February 25, 2019
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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.
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- facial swelling
If an allergic reaction occurs, stop use and seek medical help right away.
- 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
- INACTIVE INGREDIENT
SPL UNCLASSIFIED SECTION
DO NOT FLUSH
Product is not made with Natural Rubber Latex.
Cloth: 100% Polyester
©2017 Medline Industries, Inc.
Medline is a registered trademark of Medline Industries, Inc.
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)
CHLORHEXIDINE GLUCONATE 2%
PATIENT PREOPERATIVE SKIN PREPARATION CLOTH
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
SINGLE USE ONLY.
FOR EXTERNAL USE ONLY.
DO NOT MICROWAVE
2 9 X 10.5 IN (22.9 X 26.7 CM) DISPOSABLE CLOTHS
INGREDIENTS AND APPEARANCE
chlorhexidine gluconate 2% cloth
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 500 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) DIMETHICONE 350 (UNII: 2Y53S6ATLU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-244-02 24 in 1 CARTON 01/14/2019 1 NDC:53329-244-01 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207964 01/14/2019 Labeler - Medline Industries (025460908)