Northside Hospital C-section Mothers Tote
Alcohol And Sodium Monofluorophospate
Asp Global, Llc
Human Otc Drug
NDC 59448-207Northside Hospital C-section Mothers Tote also known as Alcohol And Sodium Monofluorophospate is a human otc drug labeled by 'Asp Global, Llc'. National Drug Code (NDC) number for Northside Hospital C-section Mothers Tote is 59448-207. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Northside Hospital C-section Mothers Tote drug includes . The currest status of Northside Hospital C-section Mothers Tote drug is Active.
Drug Information:
| Drug NDC: | 59448-207 |
| 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: | Northside Hospital C-section Mothers Tote |
| 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: | Alcohol And Sodium Monofluorophospate |
| 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: | 17 May, 2022 |
| 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: | ASP Global, LLc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 545626
581660
|
| 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 |
|---|
| 59448-207-00 | 6 BAG in 1 BOX (59448-207-00) / 1 KIT in 1 BAG * 10 g in 1 TUBE (42555-060-45) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02) * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE | 17 May, 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
Purpose anticavity
Product Elements:
Northside hospital c-section mothers tote alcohol and sodium monofluorophospate instant hand antiseptic ethyl alcohol alcohol alcohol water aloe vera leaf glycerin propylene glycol carbomer interpolymer type a (allyl sucrose crosslinked) trolamine colgate anticavity sodium monofluorophosphate sodium monofluorophosphate fluoride ion dibasic calcium phosphate dihydrate water sorbitol sodium lauryl sulfate sodium pyrophosphate saccharin sodium gilchrist and soames body butter inert water isopropyl palmitate cetostearyl alcohol glyceryl monostearate cyclomethicone 5 isopropyl myristate benzyl alcohol peg-100 stearate carbomer homopolymer type c (allyl pentaerythritol crosslinked) dehydroacetic acid sodium hydroxide gilchrist and soames hair 2 in 1 inert water sodium laureth-3 sulfate sodium chloride glycerin cocamidopropyl betaine coco monoethanolamide polyquaternium-7 (70/30 acrylamide/dadmac; 2600000 mw) citric acid monohydrate magnesium nitrate methylchloroisothiazolinone magnesium chloride methylparaben propylparaben methylisothiazolinone fd&c yellow no. 5 fd&c red no. 4 gilchrist and soames body refresher--body wash inert water sodium laureth-3 sulfate sodium chloride cocamidopropyl betaine glycerin polyquaternium-7 (70/30 acrylamide/dadmac; 2600000 mw) coco monoethanolamide magnesium nitrate citric acid monohydrate methylchloroisothiazolinone magnesium chloride methylisothiazolinone fd&c yellow no. 5 fd&c red no. 4 fd&c blue no. 1 northside hospital lip balm inert ethylhexyl palmitate medium-chain triglycerides polyisobutylene (2300 mw) yellow wax high density polyethylene sheanut oil .alpha.-tocopherol acetate phenoxyethanol asp global llc alcohol-free inert water glycerin polysorbate 20 sodium benzoate menthol, unspecified form saccharin sodium cetylpyridinium chloride fd&c blue no. 1
Indications and Usage:
Uses for hand washing to decrease bacteria on the skin. recommended for repeated use.
Use helps protect against cavities
Warnings:
Warnings flammable. keep away from fire or flame. for external use only. avoid contact with broken skin. when using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash appears and lasts. keep out of reach of children. if swallowed, get medical help.
Warnings keep out of the reach of children under 6 years of age. if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water.
Dosage and Administration:
Directions not recommended for infants. wet hands thoroughly with product and allow to dry without wiping. children under 6 years of age should be supervised when using this product.
Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
Stop Use:
Stop use and ask a doctor if irritation or rash appears and lasts.
Package Label Principal Display Panel:
Principal display panel - 53 ml bottle label northside hospital instant hand antiseptic 62% w/w ethyl alcohol creating a healing environment we provide our patients with the essentials they need to stay well rested. this is an important part of healing, both here and at home. 1.9 fl oz / 53 ml distributed by: asp global, llc 7800 third flag parkway, austell, ga 30168, usa rev 03-2021 principal display panel - 53 ml bottle label
Principal display panel - 10 g tube label p1505037 colgate ® anticavity toothpaste cavity protection net wt 10g 7 other principal display panel - 10 g tube label
Principal display panel - kit label components made in china: shampoo/conditioner, body wash, body lotion, alcohol-free mouthwash, lip balm, hand sanitizer, hairbrush, toothbrush, ear plugs, eye mask, face mask, facial tissue, pen, puzzle book, questions for my care team book, ice pack, baby bottle, insulated mug, spoon, disposable panties/briefs, cleansing bottle, emesis bag, sanitary pad component made in thailand: toothpaste kit made and assembled in china: insulated bag kit bag and kit made and assembled in the usa: tote bag lot #: exp: 1000 johnson ferry rd ne. atlanta, ga 30342 tel: (404) 851-8000 northside hospital mother's bag nsmtktc01-t creating a healing environment we provide our patients with the essentials they need to stay well rested. this is an important part of healing, both here and at home. contents/origins(on back) northside amenity kit - main includes: 2.0 fl.oz. shampoo/conditioner, 2.0 fl.oz. body wash, 2.0 fl.oz. body lotion, 2.0 fl.oz. alcohol-free mouthwash, 1.9 fl.oz. hand sanitizer, 0.15 oz. net wt. lip balm, hairbrush, toothbrush, toothpaste, ear plugs, eye mask, facial tissue, pen, puzzle book, questions for my care team book insulated bag kit includes: 2 ice packs, 2 baby bottles, 1 spoon insulated mug includes: 1 insulated mug with lid and straw, 30 oz. disposable panties/briefs includes: 6 disposable panties/briefs sanitary pad includes: 6 sanitary pads, 6.5" x 13.5" cleansing bottle includes: 1 cleansing bottle, 8 oz. emesis bag includes: 1 emesis bag, easy lock distributed by: asp global, llc 7800 third flag parkway, austell, ga 30168, usa rev 00 northside hospital item #: nsmtktc01-t description: kit, northside maternity c-section, tote po #: lot # xmmddfc exp: yyyy-mm-dd qty: 6 kit/cs carton #: xx of xx net wt.: xx kg gross wt.: xx kg cubic dimensions: 47 x 39 x 50 cm components made in china: shampoo/conditioner, body wash, body lotion, alcohol-free mouthwash, lip balm, hand sanitizer, hairbrush, toothbrush, ear plugs, eye mask, facial tissue, face mask, pen, puzzle book, questions for my care team book, ice pack, baby bottle, spoon, insulated mug, disposable panties/briefs, emesis bag, cleansing bottle, sanitary pad component made in thailand: toothpaste kit made and assembled in china: insulated bag kit bag made in china and assembled in the usa: tote bag northside hospital name card patient name: northside hospital principal display panel - kit label
Further Questions:
Questions or comments? call toll-free 1-800-468-6502