Vortex Moisturizer Nasal
Sodium Chloride
Vortex Life Sciences, Inc.
Human Otc Drug
NDC 82529-000Vortex Moisturizer Nasal also known as Sodium Chloride is a human otc drug labeled by 'Vortex Life Sciences, Inc.'. National Drug Code (NDC) number for Vortex Moisturizer Nasal is 82529-000. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Vortex Moisturizer Nasal drug includes Sodium Chloride - 6.5 mg/mL . The currest status of Vortex Moisturizer Nasal drug is Active.
Drug Information:
| Drug NDC: | 82529-000 |
| 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: | Vortex Moisturizer Nasal |
| 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 Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vortex Life Sciences, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | SODIUM CHLORIDE - 6.5 mg/mL
|
| 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: | UNAPPROVED DRUG OTHER |
| 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 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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. |
| 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: | Vortex Life Sciences, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 707251
|
| 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: | 451W47IQ8X
|
| 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 |
|---|
| 82529-000-01 | 1 BOTTLE in 1 BOX (82529-000-01) / 15 mL in 1 BOTTLE | 01 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: moisturizer
Product Elements:
Vortex moisturizer nasal sodium chloride water sodium chloride chloride ion
Indications and Usage:
Uses temporary relief of dry irritated nasal passages promotes healthy nasal passages clears and invigorates breathing
Warnings:
Warning: use only as directed. if pregnant or breastfeeding, consult with a physician before use. keep out of reach of children. stop use and consult with a physician if you experience any discomfort while using this product. in case of overdose, get medical help or contact a poison control center at 1-800-222-2222 right away.
Dosage and Administration:
Directions: sniff and inhale deeply while spraying into nostril. 12 years old - adult: 3 sprays in each nostril. 6 - 12 years old: 2 sprays in each nostril. 3 - 6 years old: 1 spray in each nostril. children under age 3: 1 spray. consult a physician. to use, remove cap, insert the nozzle into the nostril and depress the pump completely while sniffing deeply. day 1: every 3 hours, minimum 5 doses/day day 2: every 3 hours, minimum 5 doses/day day 3: 3 times a day. day 4: at bedtime. day 5: at bedtime. day 6 - 9: skip. day 10: final dose at bedtime. for moderate to severe symptoms every 3 hours (minimum 5 doses/24 hrs) until symptoms have significantly reduced. then, resume at day 3 schedule.
Stop Use:
Stop use and consult with a physician if you experience any discomfort while using this product. in case of overdose, get medical help or contact a poison control center at 1-800-222-2222 right away.
Package Label Principal Display Panel:
Package labeling: label