NDC 54365-400 Chloraprep One-step

Chlorhexidine Gluconate And Isopropyl Alcohol Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
54365-400
Proprietary Name:
Chloraprep One-step
Non-Proprietary Name: [1]
Chlorhexidine Gluconate And Isopropyl Alcohol
Substance Name: [2]
Chlorhexidine Gluconate; Isopropyl Alcohol
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • 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.
  • Labeler Name: [5]
    Carefusion 213 Llc
    Labeler Code:
    54365
    FDA Application Number: [6]
    NDA021555
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-07-2002
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 54365-400-01

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

    NDC Code 54365-400-02

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

    NDC Code 54365-400-04

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

    NDC Code 54365-400-05

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

    NDC Code 54365-400-06

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

    NDC Code 54365-400-07

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

    NDC Code 54365-400-08

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

    NDC Code 54365-400-09

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

    NDC Code 54365-400-11

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

    NDC Code 54365-400-12

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

    NDC Code 54365-400-13

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

    NDC Code 54365-400-14

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

    NDC Code 54365-400-30

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

    NDC Code 54365-400-31

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

    NDC Code 54365-400-32

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

    NDC Code 54365-400-33

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

    NDC Code 54365-400-34

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

    NDC Code 54365-400-35

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

    NDC Code 54365-400-36

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

    NDC Code 54365-400-37

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

    NDC Code 54365-400-38

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

    NDC Code 54365-400-39

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

    Product Details

    What is NDC 54365-400?

    The NDC code 54365-400 is assigned by the FDA to the product Chloraprep One-step which is 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. The product is distributed in 22 packages with assigned NDC codes 54365-400-01 25 pouch in 1 carton / 1 applicator in 1 pouch / 3 ml in 1 applicator, 54365-400-02 20 pouch in 1 carton / 1 applicator in 1 pouch / 1.5 ml in 1 applicator, 54365-400-04 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-05 1 applicator in 1 pouch / 26 ml in 1 applicator, 54365-400-06 60 pouch in 1 carton / 1 applicator in 1 pouch / 1 ml in 1 applicator, 54365-400-07 48 pouch in 1 carton / 1 applicator in 1 pouch / 1.75 ml in 1 applicator, 54365-400-08 40 pouch in 1 carton / 3 applicator in 1 pouch / 1.75 ml in 1 applicator, 54365-400-09 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-11 25 pouch in 1 carton / 1 applicator in 1 pouch / 3 ml in 1 applicator, 54365-400-12 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-13 1 applicator in 1 pouch / 26 ml in 1 applicator, 54365-400-14 1 applicator in 1 pouch / 26 ml in 1 applicator, 54365-400-30 20 pouch in 1 carton / 1 applicator in 1 pouch / 1.5 ml in 1 applicator, 54365-400-31 60 pouch in 1 carton / 1 applicator in 1 pouch / 1 ml in 1 applicator, 54365-400-32 25 pouch in 1 carton / 1 applicator in 1 pouch / 3 ml in 1 applicator, 54365-400-33 25 pouch in 1 carton / 1 applicator in 1 pouch / 3 ml in 1 applicator, 54365-400-34 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-35 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-36 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator, 54365-400-37 1 applicator in 1 pouch / 26 ml in 1 applicator, 54365-400-38 1 applicator in 1 pouch / 26 ml in 1 applicator, 54365-400-39 1 applicator in 1 pouch / 26 ml in 1 applicator. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Chloraprep One-step?

    Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.maximal treatment area using three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm 2) tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.completely wet the treatment area with antisepticdry surgical sites (e.g., abdomen or arm): using each swabstick sequentially, use gentle repeated back-and-forth strokes for a total of 30 seconds. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): using each swabstick sequentially, use gentle repeated back-and-forth strokes for a total of 2 minutes. Allow the area to air dry for approximately 1 minute. 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.

    What are Chloraprep One-step Active Ingredients?

    Which are Chloraprep One-step UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Chloraprep One-step Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Chloraprep One-step?

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".