Baylor Scott And White Hybrid Comfort
Benzalkonium Chloride
Asp Global, Llc
Human Otc Drug
NDC 59448-900Baylor Scott And White Hybrid Comfort also known as Benzalkonium Chloride is a human otc drug labeled by 'Asp Global, Llc'. National Drug Code (NDC) number for Baylor Scott And White Hybrid Comfort is 59448-900. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Baylor Scott And White Hybrid Comfort drug includes . The currest status of Baylor Scott And White Hybrid Comfort drug is Active.
Drug Information:
| Drug NDC: | 59448-900 |
| 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: | Baylor Scott And White Hybrid Comfort |
| 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: | Asp Global, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | part333E |
| 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: | ASP Global, LLc
|
| 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. |
| UNII: | |
| 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 |
|---|
| 59448-900-00 | 1 KIT in 1 BAG (59448-900-00) * 60 mL in 1 TUBE * 4.25 g in 1 TUBE * 10 APPLICATOR in 1 PACKAGE (59448-010-01) / 6.2 g in 1 APPLICATOR | 15 Mar, 2022 | 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:
Baylor scott and white hybrid comfort benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium chloride benzalkonium aloe vera leaf water ethylparaben phenoxyethanol dmdm hydantoin polysorbate 20 edetate disodium anhydrous methylparaben sodium citrate, unspecified form baylor scott white body water mineral oil glycerin petrolatum dimethicone peg-100 stearate shea butter stearyl alcohol cetyl alcohol glyceryl 1-stearate hydroxyacetophenone 1,2-hexanediol allantoin xanthan gum carbomer homopolymer, unspecified type edetate disodium anhydrous sodium hydroxide asp global lip balm ethylhexyl palmitate medium-chain triglycerides polyisobutylene (2300 mw) yellow wax high density polyethylene sheanut oil .alpha.-tocopherol acetate phenoxyethanol
Indications and Usage:
Use for preparation of the skin prior to an injection.
Warnings:
Warnings for external use only. flammable, keep away from fire or flame. do not use with electrocautery procedures or near eyes. stop use and ask a doctor if irritation or redness develops. keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.
Dosage and Administration:
Directions apply topically as needed to clean intended area. discard after single use.
Package Label Principal Display Panel:
Principal display panel - kit label baylorscott&white health item #: bswhyb01 description: kit, baylor scott & white hybrid comfort po #: lot #: xmmddfc exp: yyyy-mm-dd qty: 20 kit/cs carton #: xxx of xxx net wt.: xx.x kg gross wt.: xx.x kg cubic dimensions: xx x xx x xx cm made in china components: hand/body lotion lip balm sleep mask ear plugs puzzle book care book door hanger playing cards pen hair brush stress ball hand sanitizing wipes kit case for your comfort and healing, we hope to make your hospital experience as quiet and peaceful as possible. while it is not always feasible to stop all noise as we actively care for our patients, it is our priority to keep noise levels low, especially at night. if we are not meeting your expectations, please let us know. thank you for trusting baylor scott & white with your care! baylorscott&white health contents/origins: 2.0 fl. oz. hand/body lotion 0.15 oz. net wt. lip balm sleep mask, ear plugs, puzzle book, care book, door hanger, playing cards, pen, hair brush, stress ball, hand sanitizing wipes, and kit case: made in china lot #: exp: distributed by: asp global, llc 7800 third flag parkway, austell, ga 30168, usa baylorscott&white health rev 00 baylorscott&white health principal display panel - kit label
Principal display panel - 6.2 g applicator label baylorscott&white health open principal display panel - 6.2 g applicator label