READYPREP CHG- chlorhexidine gluconate 2% cloth

ReadyPrep CHG by

Drug Labeling and Warnings

ReadyPrep CHG by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)