Newyork-presbyterian Amenity
Sodium Monofluorophospate
Asp Global, Llc
Human Otc Drug
NDC 59448-100Newyork-presbyterian Amenity also known as Sodium Monofluorophospate is a human otc drug labeled by 'Asp Global, Llc'. National Drug Code (NDC) number for Newyork-presbyterian Amenity is 59448-100. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Newyork-presbyterian Amenity drug includes . The currest status of Newyork-presbyterian Amenity drug is Active.
Drug Information:
| Drug NDC: | 59448-100 |
| 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: | Newyork-presbyterian Amenity |
| 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: | 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 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 Jul, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 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: | part355 |
| 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
|
| 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: | 0840216105881
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 59448-100-00 | 1 KIT in 1 BAG (59448-100-00) * 4.25 g in 1 TUBE * 28 g in 1 CELLO PACK * 65 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (42555-060-45) * 60 mL in 1 TUBE * 60 mL in 1 TUBE * 60 mL in 1 TUBE | 01 Jul, 2013 | 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 anticavity
Product Elements:
Newyork-presbyterian amenity sodium monofluorophospate 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 gilchrist and soames moisturizing lip balm inert ceresin ethylhexyl palmitate mineral oil petrolatum hydrogenated polybutene (1300 mw) polybutene (1400 mw) microcrystalline wax candelilla wax silicon dioxide pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) propylparaben fd&c yellow no. 5 acid blue 9 ammonium asp global, llc alcohol-free inert water glycerin polysorbate 20 sodium benzoate menthol, unspecified form saccharin sodium cetylpyridinium chloride fd&c blue no. 1 asp global, llc cleansing glycerene bar inert sodium palmitate sodium cocoate water glycerin sodium chloride palmitic acid edetic acid titanium dioxide
Indications and Usage:
Use helps protect against cavities
Warnings:
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.
Dosage and Administration:
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
Package Label Principal Display Panel:
Principal display panel - 10 g tube label colgate ® anticavity toothpaste cavity protection principal display panel - 10 g tube label
Principal display panel - amenity kit newyork-presbyterian we are pleased to present this welcome kit for your comfort and convenience during your stay. thank you for choosing new york-presbyterian for your healthcare! contents/origins: 2.0 fl. oz. shampoo/conditioner 2.0 fl. oz. body wash 2.0 fl. oz. body lotion 2.2 fl. oz. alcohol-free mouthwash 0.15 oz. net wt. lip balm 0.85 oz. net wt. soap bar hair brush, toothbrush, ear plugs, sleep mask and kit case: made in china toothpaste: made in thailand lawson #: 440016 lot #: exp: distributed by: asp global, llc 7800 third flag parkway, austell, ga 30168, usa 440016-i-a rev 3 amenity kit - adult made in china: shampoo/conditioner body wash body lotion alcohol-free mouthwash hair brush toothbrush ear plugs facial soap lip moisturizer sleep mask kit case made in thailand: toothpaste ref#: 440016 qty: 20 kit/cs gross weight: 10.5 kg lot #: xmmddfc exp: yyyy-mm-dd 1 single patient use not made with natural rubber latex distributed by: asp global, llc 7800 third flag parkway, austell, ga 30168, usa newyork-presbyterian the university hospital of columbia and cornell principal display panel - amenity kit
Further Questions:
Questions or comments? call toll-free 1-800-468-6502