NDC 53329-244 Readyprep Chg

Chlorhexidine Gluconate 2%

NDC Product Code 53329-244

NDC 53329-244-02

Package Description: 24 POUCH in 1 CARTON > 2 CLOTH in 1 POUCH (53329-244-01)

NDC Product Information

Readyprep Chg with NDC 53329-244 is a a human over the counter drug product labeled by Medline Industries. The generic name of Readyprep Chg is chlorhexidine gluconate 2%. The product's dosage form is cloth and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 846127.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Readyprep Chg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Medline Industries
Labeler Code: 53329
FDA Application Number: NDA207964 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-14-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Readyprep Chg Product Label Images

Readyprep Chg Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Chlorhexidine gluconate 2% solution

Otc - Purpose

Antiseptic

Uses

  • Helps reduce bacteria that can potentially cause skin infectionfor 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 productfor lumbar punctures or in contact with the meningeson open skin woundsas 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 breathingshockfacial swellinghivesrashIf 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 microwaveproduct 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 contaminationuse 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 useafter package has been opened, discard any unused cloths

Other Information

  • Store product flatstore between 20-25 degrees Celsius (68-77 degrees Fahrenheit)avoid excessive heat above 40 degrees Celsius (104 degrees Fahrenheit)

Inactive Ingredient

  • Benzalkonium chloridedimethicone emulsionglycerinisopropyl alcoholpropylene glycolpurified water USP

Other

DO NOT FLUSHNon-Sterile.Product is not made with Natural Rubber Latex.Cloth: 100% PolyesterREF MSC095CHGwww.medline.com©2017 Medline Industries, Inc.Medline is a registered trademark of Medline Industries, Inc.Manufactured byMedline Industries, Inc.,Northfield, IL 60093 USA.Made in USA with domestic and foreign materials.Questions, comments, or ordering call: 1-800-MEDLINECustomer Service Hours:(Monday to Friday, 7 AM to 7 PM CST)RI17MSC

Pouch Label

READYPREPTM CHGCHLORHEXIDINE GLUCONATE 2%PATIENT PREOPERATIVE SKIN PREPARATION CLOTH
NON-STERILEEQUIVALENT TO 500MG CHLORHEXIDINE GLUCONATE PER CLOTHProvides 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 FREERINSE FREESINGLE USE ONLY.FOR EXTERNAL USE ONLY.DO NOT MICROWAVE2 9 X 10.5 IN (22.9 X 26.7 CM) DISPOSABLE CLOTHSREF MSC095CHG

* Please review the disclaimer below.