Fortify
Menthol
Saje Natural Business Inc.
Human Otc Drug
NDC 70983-002Fortify also known as Menthol is a human otc drug labeled by 'Saje Natural Business Inc.'. National Drug Code (NDC) number for Fortify is 70983-002. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Fortify drug includes Menthol - 24 mg/mL . The currest status of Fortify drug is Active.
Drug Information:
| Drug NDC: | 70983-002 |
| 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: | Fortify |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Saje Natural Business Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| 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: | MENTHOL - 24 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 16 Oct, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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, 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: | Saje Natural Business 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. |
| UNII: | L7T10EIP3A
|
| 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 |
|---|
| 70983-002-03 | 1 BOTTLE, DROPPER in 1 BOX (70983-002-03) / 30 mL in 1 BOTTLE, DROPPER | 16 Oct, 2016 | N/A | No |
| 70983-002-04 | 1 BOTTLE, DROPPER in 1 BOX (70983-002-04) / 10 mL in 1 BOTTLE, DROPPER | 16 Oct, 2016 | N/A | No |
| 70983-002-05 | 1 BOTTLE, DROPPER in 1 BOX (70983-002-05) / 6 mL in 1 BOTTLE, DROPPER | 16 Oct, 2016 | 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 antitussive (cough suppressant) uses temporarily calms cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves the impulse to cough to help you rest.
Product Elements:
Fortify menthol cinnamon oil eucalyptus oil tea tree oil pelargonium graveolens flower oil peppermint oil pine needle oil (pinus sylvestris) rosemary oil grape seed oil menthol menthol clear oil
Indications and Usage:
Directions see important warnings under 'when using this product'. adults and children 12 years of age and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth
Warnings:
Warnings for external use only. do not take by mouth or place in nostrils flammable : keep away from fire or flame.
Do Not Use:
Warnings for external use only. do not take by mouth or place in nostrils flammable : keep away from fire or flame.
When Using:
When using this product, do not heat microwave use near an open flame add to hot water or any container where heating water. may cause splattering and result in burns.
Dosage and Administration:
Use up to three times daily or as directed by a doctor. children under 12 years of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition.
Package Label Principal Display Panel:
Fortify antitussive (cough suppressant) oil blend rub - 30 ml saje® natural wellness fortify antitussive (cough suppressant) oil blend rub 1 fl. oz. | 30 ml - fortify 30 ml r3
Fortify antitussive (cough suppressant) oil blend rub - 10 ml saje® natural wellness fortify antitussive (cough suppressant) oil blend rub 0.34 fl. oz. | 10 ml - fortify 10 ml v4
Fortify antitussive (cough suppressant) oil blend rub - 6 ml saje® natural wellness fortify antitussive (cough suppressant) oil blend rub 0.2 fl. oz. | 6 ml - fortify 6 ml r3
Further Questions:
Questions? 1-877-275-7253 distributed by: saje natural wellness 22 east 5th ave. vancouver, bc canada v5t 1g8 | saje.com | @sajewellness | 1-877-275-7253 | made in canada