Antibacterial Bathing
Benzalkonium Chloride
Cardinal Health, Inc.
Human Otc Drug
NDC 63517-210Antibacterial Bathing also known as Benzalkonium Chloride is a human otc drug labeled by 'Cardinal Health, Inc.'. National Drug Code (NDC) number for Antibacterial Bathing is 63517-210. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Antibacterial Bathing drug includes Benzalkonium Chloride - 1.3 mg/mL . The currest status of Antibacterial Bathing drug is Active.
Drug Information:
| Drug NDC: | 63517-210 |
| 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: | Antibacterial Bathing |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | BENZALKONIUM CHLORIDE - 1.3 mg/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: | OTC MONOGRAPH NOT FINAL |
| 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: | 15 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jun, 2026 |
| 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: | part333A |
| 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: | Cardinal Health, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1038558
|
| 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. |
| UPC: | 0888499011437
|
| UPC stands for Universal Product Code. |
| UNII: | F5UM2KM3W7
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63517-210-22 | 8 POUCH in 1 PACKET (63517-210-22) / 1 PATCH in 1 POUCH / 13.775 mL in 1 PATCH | 15 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:
Purpose antiseptic
Product Elements:
Antibacterial bathing benzalkonium chloride water phenoxyethanol sodium benzoate aloe vera leaf myristamidopropyl propylene glycol-dimonium chloride phosphate linoleamidopropyl propylene glycol-dimonium chloride phosphate citric acid monohydrate edetate disodium anhydrous allantoin benzalkonium chloride benzalkonium
Indications and Usage:
Uses to decrease bacteria on skin
Warnings:
Warnings for external use only do not heat sealed package in microwave ask a doctor before you use if you have: deep puncture wounds animal bites serious burns keep out of reach of children. in case of accidental ingestion seek medical help or contact a poison control center immediately. gloves diminish sensitivity to heat closely monitor heat level with infants, unresponsive or skin sensitive individuals do not use in the eye longer than 1 week unless directed by a physician over raw surfaces or blistered areas
Do Not Use:
Warnings for external use only do not heat sealed package in microwave ask a doctor before you use if you have: deep puncture wounds animal bites serious burns keep out of reach of children. in case of accidental ingestion seek medical help or contact a poison control center immediately. gloves diminish sensitivity to heat closely monitor heat level with infants, unresponsive or skin sensitive individuals do not use in the eye longer than 1 week unless directed by a physician over raw surfaces or blistered areas
Dosage and Administration:
Directions cloths can be used at room temperature or heated in a wipes warmer for extra comfort. warming instructions: single warming session at temperatures not to exceed 52Ëc (125Ëf) and for a maximum of 200 hours. discard wipes that have been exposed to warming temperatures exceeding 52Ëc (125Ëf) or stored longer than 200 hours in the warmer. bathing instructions: remove one cloth at a time to clean each area in the following order: 1. neck & facial area; 2. front torso; 3. right arm; 4. left arm; 5. right leg; 6. left leg; 7. back torso; 8. buttocks & perineal area allow skin to dry dispose of cloth in waste receptacle do not flush cloths in toilet
Package Label Principal Display Panel:
Package labeling: label