Baby Essentials Gift Set
Benzalkonium Chloride
Kas Direct Llc Dba Babyganics
Human Otc Drug
NDC 59062-5000Baby Essentials Gift Set also known as Benzalkonium Chloride is a human otc drug labeled by 'Kas Direct Llc Dba Babyganics'. National Drug Code (NDC) number for Baby Essentials Gift Set is 59062-5000. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Baby Essentials Gift Set drug includes . The currest status of Baby Essentials Gift Set drug is Active.
Drug Information:
| Drug NDC: | 59062-5000 |
| 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: | Baby Essentials Gift Set |
| 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: | Kas Direct Llc Dba Babyganics |
| 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 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: | 01 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | 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: | KAS Direct LLC dba BabyGanics
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 59062-5000-1 | 1 KIT in 1 PACKAGE (59062-5000-1) * 207 mL in 1 BOTTLE * 25 CLOTH in 1 PACKAGE * 50 mL in 1 BOTTLE, PUMP (59062-4000-5) * 89 mL in 1 BOTTLE, DISPENSING * 266 mL in 1 BOTTLE * 266 mL in 1 BOTTLE | 01 Jan, 2015 | 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 antimicrobial
Product Elements:
Baby essentials gift set benzalkonium chloride moisturizing daily water cocoa butter cetyl alcohol squalene decyl oleate shea butter propanediol glycerin avocado oil olive oil canola oil tocopherol aloe vera leaf tomato seed oil sunflower oil cranberry seed oil nigella sativa seed raspberry seed oil cetostearyl alcohol polyoxyl 20 cetostearyl ether stearic acid yellow wax carbomer homopolymer, unspecified type sodium hydroxide caprylyl glycol trisodium ethylenediamine disuccinate sorbic acid phenoxyethanol bubble bath water sodium lauroyl methyl isethionate disodium cocoamphodiacetate coco glucoside lauryl glucoside capryl/capramidopropyl betaine tomato seed oil sunflower oil cranberry seed oil nigella sativa seed raspberry seed oil aloe vera leaf calendula officinalis flower chamomile olea europaea leaf glycerin citric acid monohydrate trisodium ethylenediamine disuccinate phenoxyethanol ethylhexylglycerin sodium benzoate squeeze and foam shampoo plus body wash water sodium lauroyl methyl isethionate caprylyl/capryl oligoglucoside propanediol butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) sodium lauroyl oat amino acids glycerin ethylhexylglycerin citric acid monohydrate trisodium ethylenediamine disuccinate dehydroacetic acid tomato seed oil sunflower oil cranberry seed oil nigella sativa seed raspberry seed oil phenoxyethanol sodium hydroxide phytate sodium aloe vera leaf cucumber chamomile avocado tocopherol babyganics alcohol-free foaming hand sanitizer mandarin benzalkonium chloride benzalkonium chloride benzalkonium water cetrimonium chloride laurtrimonium chloride dihydroxyethyl cocamine oxide glycereth-17 cocoate medium-chain triglycerides triethyl citrate tangerine tocopherol orange oil citrus maxima fruit rind oil toy, table and highchair wipes water glycerin decyl glucoside malic acid potassium sorbate gluconolactone sodium benzoate direct black 19 foaming dish and bottle soap water cocamidopropyl hydroxysultaine lauramine oxide decyl glucoside sodium lauroyl sarcosinate glycerin methylisothiazolinone
Indications and Usage:
Uses for hand sanitizing to decrease bacteria on the skin recommended for repeated use
Warnings:
Warnings for external use only when using this product avoid contact with eyes. in case of eye contact, ï¬ush eyes with water. stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes. in case of eye contact, ï¬ush eyes with water.
Dosage and Administration:
Directions pump a small amount of foam into palm of hand rub thoroughly over all surfaces of both hands rub hands together briskly until dry
Stop Use:
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Package Label Principal Display Panel:
Principal display panel - kit package babyganics baby essentials gift set 1- daily lotion chamomile verbena (9 fl oz) 1- bubble bath chamomile verbena (9 fl oz) 1- foaming shampoo+body wash chamomile verbena (7 fl oz) 1- foaming dish & bottle soap fragrance free (3 fl oz) 1- toy, table & highchair wipes fragrance free (25 wipes) 2- alcohol-free foaming hand sanitizer mandarin (50 ml) discover which ingredients are certified organic on bottom panel. principal display panel - kit package