Chloraprep One-step
Chlorhexidine Gluconate And Isopropyl Alcohol
Carefusion 213, Llc
Human Otc Drug
NDC 54365-400Chloraprep One-step also known as Chlorhexidine Gluconate And Isopropyl Alcohol is a human otc drug labeled by 'Carefusion 213, Llc'. National Drug Code (NDC) number for Chloraprep One-step is 54365-400. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Chloraprep One-step drug includes Chlorhexidine Gluconate - 20 mg/mL Isopropyl Alcohol - .7 mL/mL . The currest status of Chloraprep One-step drug is Active.
Drug Information:
| Drug NDC: | 54365-400 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Chloraprep One-step |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Chlorhexidine Gluconate And Isopropyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Carefusion 213, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLORHEXIDINE GLUCONATE - 20 mg/mL
ISOPROPYL ALCOHOL - .7 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA020832 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | CareFusion 213, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 858726
998282
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | MOR84MUD8E
ND2M416302
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54365-400-38 | 1 APPLICATOR in 1 POUCH (54365-400-38) / 26 mL in 1 APPLICATOR | 24 May, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes antiseptic antiseptic
Product Elements:
Chloraprep one-step chlorhexidine gluconate and isopropyl alcohol water chlorhexidine gluconate chlorhexidine isopropyl alcohol isopropyl alcohol fd&c yellow no. 6
Indications and Usage:
Use for the preparation of the patientâs skin prior to surgery. helps to reduce bacteria that potentially can cause skin infection.
Warnings:
Warning 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 surgery or on an area smaller than 8.4 in. x 8.4 in . use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid 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 pool remove wet materials from prep area
Warnings for external use only. flammable, keep away from fire or flame. to reduce risk of fire, prep carefully: do not use 26-ml applicator for head and neck surgery do not use on an area smaller than 8.4 in. x 8.4 in . use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid 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 pool remove wet materials from prep area
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.
Do Not Use:
Warning 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 surgery or on an area smaller than 8.4 in. x 8.4 in . use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid 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 pool remove wet materials from prep area
Warnings for external use only. flammable, keep away from fire or flame. to reduce risk of fire, prep carefully: do not use 26-ml applicator for head and neck surgery do not use on an area smaller than 8.4 in. x 8.4 in . use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid 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 pool remove wet materials from prep area
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.
When Using:
When using this product keep out of eyes, ears, and mouth. may cause serious or permanent injury if permitted to enter and remain. if contact occurs, rinse with cold water right away and contact a doctor.
Dosage and Administration:
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 area ⢠maximal treatment area for one applicator is approximately 13.2 in. x 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 surgery ⢠remove applicator from package; do not touch sponge ⢠hold the applicator with the sponge down. pinch wing only 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 skin ⢠completely wet the treatment area with antiseptic ⢠dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds ⢠moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strok
Read more...es for 2 minutes ⢠do not allow solution to pool; tuck prep towels to absorb solution, and then remove ⢠allow 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.
Stop Use:
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. these may be signs of a serious condition.
Package Label Principal Display Panel:
Package label package label bd chloraprep hi-lite orange 26 ml applicator 2% w/v chlorhexidine gluconate (chg) and 70% v/v isopropyl alcohol (ipa) patient preoperative skin preparation sterile solution applicator is sterile if package is intact ref 930815 ndc 54365-400-38 hi lite orange external use only professional use only sterile eo sterile solution carefusion 213, llc, el paso, tx 79912, subsidiary of becton, dickinson and co. made in the usa of us and imported parts www.bd.com 54365-400-38.jpg
Further Questions:
Questions? www.chloraprep.com ⢠call 1-800-523-0502 (m-f 8 a.m.-5 p.m. cst)