NDC 54365-400 Chloraprep One-step

Chlorhexidine Gluconate And Isopropyl Alcohol

NDC Product Code 54365-400

NDC 54365-400-01

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR

NDC 54365-400-02

Package Description: 20 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 1.5 mL in 1 APPLICATOR

NDC 54365-400-03

Package Description: 200 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > .67 mL in 1 APPLICATOR

NDC 54365-400-04

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-05

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC 54365-400-06

Package Description: 60 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 1 mL in 1 APPLICATOR

NDC 54365-400-07

Package Description: 48 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 1.75 mL in 1 APPLICATOR

NDC 54365-400-08

Package Description: 40 POUCH in 1 CARTON > 3 APPLICATOR in 1 POUCH > 1.75 mL in 1 APPLICATOR

NDC 54365-400-09

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-11

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR

NDC 54365-400-12

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-13

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC 54365-400-14

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC 54365-400-30

Package Description: 20 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 1.5 mL in 1 APPLICATOR

NDC 54365-400-31

Package Description: 60 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 1 mL in 1 APPLICATOR

NDC 54365-400-32

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR

NDC 54365-400-33

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 3 mL in 1 APPLICATOR

NDC 54365-400-34

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-35

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-36

Package Description: 25 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 10.5 mL in 1 APPLICATOR

NDC 54365-400-37

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC 54365-400-38

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC 54365-400-39

Package Description: 1 APPLICATOR in 1 POUCH > 26 mL in 1 APPLICATOR

NDC Product Information

Chloraprep One-step with NDC 54365-400 is a a human over the counter drug product labeled by Carefusion 213 Llc. The generic name of Chloraprep One-step is chlorhexidine gluconate and isopropyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Carefusion 213 Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Chloraprep One-step 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.

  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL
  • CHLORHEXIDINE GLUCONATE 20 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL

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.

  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • WATER (UNII: 059QF0KO0R)

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Carefusion 213 Llc
Labeler Code: 54365
FDA Application Number: NDA021555 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: 10-07-2002 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Chloraprep One-step 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

Active Ingredients

Chlorhexidine gluconate 2% w/vIsopropyl alcohol 70% v/v

Purposes

AntisepticAntiseptic

Use

For the preparation of the patient's skin prior tosurgery. Helps to reduce bacteria that potentially can causeskin infection.

Warnings

  • For external use only. Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY:do not use 26-mL applicator for head and neck surgerydo not use on an area smaller than 8.4 in. × 8.4 in. Use a smaller applicator instead.solution contains alcohol and gives off
  • Flammable vaporsavoid getting solution into hairy areas. Hair may take up to 1 hour to dry.
  • Wet hair is flammable.do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)do not allow solution to poolremove wet materials from prep area

Allergy Alert:

  • This product may cause a severe allergicreaction. Symptoms may include:wheezing/difficulty breathingshockfacial swellinghivesrashIf an allergic reaction occurs, stop use and seek medical helpright away.

Do Not Use

  • On patients allergic to chlorhexidine gluconate or any other ingredient in this productfor lumbar puncture or in contact with meningeson open skin wounds or as a general skin cleanser

When Using This Product

Keep out of eyes, ears, and mouth.May cause serious or permanent injury if permitted to enterand remain. If contact occurs, rinse with cold water right awayand contact a doctor.

Stop Use And Ask A Doctor If

Irritation, sensitization, or allergicreaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical helpor contact a Poison 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.use in a well ventilated areamaximal treatment area for one applicator is approximately 13.2 in. × 13.2 in. (1126 cm 2). Do not use 26-ml applicator for area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.Do not use 26-ml applicator for head and neck surgeryremove applicator from package; do not touch spongehold the applicator with the sponge down. Pinch wingonly once to activate the ampules and release the antiseptic.
  • Wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skincompletely wet the treatment area with antisepticdry surgical sites (e.g., abdomen or arm): use gentle
  • Repeated back-and-forth strokes for 30 secondsmoist surgical sites (e.g., inguinal fold): use gentle
  • Repeated back-and-forth strokes for 2 minutesdo not allow solution to pool; tuck prep towels to absorb solution, and then removeallow the solution to completely dry (minimum of 3
  • Minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Other Information

  • Store between 15-30 °C (59-86 °F)avoid freezing and excessive heat above 40 °C (104 °F)

Inactive Ingredients

FD&C green #3 dye, USP purified water

Questions?

  • Www.chloraprep.comcall
  • 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

* Please review the disclaimer below.

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