FDA Label for Readyprep Chg
View Indications, Usage & Precautions
Readyprep Chg Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Chlorhexidine gluconate 2% solution
Otc - Purpose
Antiseptic
Uses
- helps reduce bacteria that can potentially cause skin infection
- for preparation of skin prior to surgery
Warnings
For external use only
Otc - 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
- as a general skin cleanser
Otc - Stop Use
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Otc - When Using
- 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.
Otc - Keep Out Of Reach Of Children
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
Other
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
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
* Please review the disclaimer below.