Olive Leaf Nasal
Nasal Spray
Vitality Works, Inc.
Human Otc Drug
NDC 64616-039Olive Leaf Nasal also known as Nasal Spray is a human otc drug labeled by 'Vitality Works, Inc.'. National Drug Code (NDC) number for Olive Leaf Nasal is 64616-039. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Olive Leaf Nasal drug includes Baptisia Tinctoria - 4 [hp_X]/mL . The currest status of Olive Leaf Nasal drug is Active.
Drug Information:
| Drug NDC: | 64616-039 |
| 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: | Olive Leaf 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: | Nasal Spray |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vitality Works, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | BAPTISIA TINCTORIA - 4 [hp_X]/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 HOMEOPATHIC |
| 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: | 07 Jan, 2003 |
| 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. |
| 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: | Vitality Works, Inc.
|
| 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: | 0019277000415
|
| UPC stands for Universal Product Code. |
| UNII: | 5K1UO2888Y
|
| 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 |
|---|
| 64616-039-02 | 1 BOTTLE, SPRAY in 1 CARTON (64616-039-02) / 30 mL in 1 BOTTLE, SPRAY (64616-039-01) | 07 Jan, 2003 | 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:
Olive leaf nasal spray baptisia tinctoria - temporary relief for diificulty breathing, mucous blockage, swelling of mucous membranes, running or blocked nose, sinus pressure and congestion, accumulation of fluid.
Product Elements:
Olive leaf nasal nasal spray benzalkonium chloride water sodium chloride xylitol sodium hydroxide baptisia tinctoria baptisia tinctoria cobalt disodium edetate olea europaea leaf
Indications and Usage:
Olive leaf nasal spray a homeopathic remedy for the temporary relief of cold and sinus irritations.
Warnings:
Olive leaf nasal spray do not exceed recommended dosage. this product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal doscharge. the use of this container by more than one person my spread infection. for your safety there is a full body seal over bottle printed "sealed for your protection". do not use if seal is broken or missing. if pregnant or breastfeeding ask a health care professional before use.
Dosage and Administration:
Olive leaf nasal spray remove the protective cap. with your head held upright insert nozzel into nostril and depress pump completely while breathing in through your nose. when finished, wipe nozzel clean and replace cap. adults and children 13 years and older, use 1-3 sprays in each nostril every 2-4 hours or as needed. children 3-12 years, half the adult dosage. children under 3 years of age, consult a health care professional.
Package Label Principal Display Panel:
Olive leaf nasal spray olive leaf nasal spray label olive leaf nasal spray carton
Further Questions:
To report any serious adverse event, call 1-888-505-4283. www.seagteproducts.com distributed by: fishery fishery development services inc. san diego, ca 92123