NDC 70983-002 Fortify

Menthol

NDC Product Code 70983-002

NDC 70983-002-03

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 30 mL in 1 BOTTLE, DROPPER

NDC 70983-002-04

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 10 mL in 1 BOTTLE, DROPPER

NDC 70983-002-05

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 6 mL in 1 BOTTLE, DROPPER

NDC Product Information

Fortify with NDC 70983-002 is a a human over the counter drug product labeled by Saje Natural Business Inc.. The generic name of Fortify is menthol. The product's dosage form is oil and is administered via topical form.

Labeler Name: Saje Natural Business Inc.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fortify Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 24 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Saje Natural Business Inc.
Labeler Code: 70983
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-16-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Fortify Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

Do not use if security seal around bottle is broken or missing.

Drug Factsactive Ingredient

Menthol 2.7%

Otc - 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.

Warnings

For external use only.Do not take by mouth or place in nostrilsFlammable: Keep away from fire or flame.

Do Not Use

  • If epileptic with high blood pressure

Ask A Doctor Before Use If You Have

  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessive phlegm (mucus).

When Using This Product, Do Not

  • Heatmicrowaveuse near an open flameadd to hot water or any container where heating water.  May cause splattering and result in burns.

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.

If Pregnant Or Breast-Feeding,

Do not use this product.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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 layercover with a warm, dry cloth if desiredclothing should be loose about throat and chest to help vapors reach the nose and mouth

Dosage & Administration

  • Use up to three times daily or as directed by a doctor.Children under 12 years of age: ask a doctor.

Other Information

  • Close container tightly and store at room temperature away from heat

Inactive Ingredients

Cinnamon oil, eucalyptus oil, melaleuca alternifolia (tea tree) leaf oil, pelargonium graveolens oil, peppermint oil, pine needle oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

Questions?

1-877-275-7253Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made in Canada

Fortify 30 Ml

SKU 332001

Fortify 10 Ml

SKU 431301

Fortify 6 Ml

LIFT HERESKU 439901

Disposal And Waste Handling

We support recycling. Please recycle where possible.

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 30 Ml

Saje® Natural WellnessFortifyAntitussive (Cough Suppressant) Oil Blend RubFor external use only. 1 fl. oz. | 30 ml

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 10 Ml

FortifySaje® Natural WellnessFortifyAntitussive (Cough Suppressant) Oil Blend RubFor external use only.0.34 fl. oz. | 10 ml

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 6 Ml

FortifySaje® Natural WellnessFortifyAntitussive (Cough Suppressant) Oil Blend RubFor external use only.0.2 fl. oz. | 6 ml

* Please review the disclaimer below.