Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health
Levmetamfetamine
Topco Associates Llc
Human Otc Drug
NDC 36800-294Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health also known as Levmetamfetamine is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health is 36800-294. This drug is available in dosage form of Inhalant. The names of the active, medicinal ingredients in Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health drug includes Levmetamfetamine - 50 mg/1 . The currest status of Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health drug is Active.
Drug Information:
| Drug NDC: | 36800-294 |
| 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: | Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Vapor Inhaler |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | levmetamfetamine nasal decongestant, TopCare health |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Levmetamfetamine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Topco Associates Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Inhalant |
| 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: | LEVMETAMFETAMINE - 50 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | NASAL
|
| 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: | 19 Feb, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | part341 |
| 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, 2024 |
| 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: | Topco Associates LLC
|
| 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. |
| UPC: | 0036800224797
|
| UPC stands for Universal Product Code. |
| UNII: | Y24T9BT2Q2
|
| 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 |
|---|
| 36800-294-07 | 1 INHALER in 1 BLISTER PACK (36800-294-07) / 198 INHALANT in 1 INHALER | 19 Feb, 2021 | 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 nasal decongestant
Product Elements:
Vapor inhaler levmetamfetamine nasal decongestant, topcare health levmetamfetamine levmetamfetamine levmetamfetamine bornyl acetate camphor (synthetic) lavender oil menthol methyl salicylate
Indications and Usage:
Use: for temporary relief of nasal congestion due to the common cold hay fever or upper respiratory allergies
Warnings:
Warnings when using this product do not exceed recommended dosage temporary burning, stinging, sneezing, or increased nasal discharge may occur use of this container by more than one person may spread infection do not use for more than 7 days use only as directed frequent or prolonged use may cause nasal congestion to recur or worsen stop use and ask a doctor if symptoms persist if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings when using this product do not exceed recommended dosage temporary burning, stinging, sneezing, or increased nasal discharge may occur use of this container by more than one person may spread infection do not use for more than 7 days use only as directed frequent or prolonged use may cause nasal congestion to recur or worsen stop use and ask a doctor if symptoms persist if pregnant or breast-feeding, ask a health professional before use. 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 do not exceed recommended dosage temporary burning, stinging, sneezing, or increased nasal discharge may occur use of this container by more than one person may spread infection
Dosage and Administration:
Directions the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine do not use more often than every 2 hours adults and children 12 years of age and over 2 inhalations in each nostril children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril children under 6 years of age ask a doctor children under 2 years of age do not use
Stop Use:
Stop use and ask a doctor if symptoms persist
Package Label Principal Display Panel:
Principal display panel - 198 mg blister pack label ndc 36800-294-07 +topcare ® health⢠vapor inhaler our pharmacists recommended levmetamfetamine - nasal decongestant temporary relief of nasal congestion due to: ⢠colds ⢠hay fever ⢠upper respiratory allergies net wt 0.007 oz (198mg) principal display panel - 198 mg blister pack label
Principal display panel - 198 mg inhaler label ndc 36800-294-07 +topcare ® health⢠vapor inhaler levmetamfetamine - nasal decongestant net wt 0.007 oz (198mg) principal display panel - 198 mg inhaler label