FORTIFY (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]

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FORTIFY (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]
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NDC 70983-002-03, 70983-002-04, 70983-002-05
Set ID 0320a305-99d1-4909-94cc-cd6509ecb948
Category HUMAN OTC DRUG LABEL
Packager Saje Natural Business Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

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

  • DRUG FACTS Active ingredient

    Menthol 2.7%

  • 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 nostrils

    Flammable: 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 emphysema
    • cough accompanied by excessive phlegm (mucus).
  • 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.
  • 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 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
  • 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?

    1-877-275-7253

    Distributed by: SAJE NATURAL WELLNESS 22 East 5th Ave. Vancouver, BC Canada V5T 1G8 | saje.com | @sajewellness | 1-877-275-7253 | Made in Canada

  • SPL UNCLASSIFIED SECTION

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

  • Fortify 30 ml

    SKU 332001

  • Fortify 10 ml

    SKU 431301

  • Fortify 6 ml

    SKU 439901

  • DISPOSAL AND WASTE HANDLING

    Please recycle where possible.

  • 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

  • INGREDIENTS AND APPEARANCE
    FORTIFY 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeFREEFORM (oil) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-002-031 in 1 BOX10/16/2016
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:70983-002-041 in 1 BOX10/16/2016
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:70983-002-051 in 1 BOX10/16/2016
    36 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/16/2016
    Labeler - Saje Natural Business Inc. (203413380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(70983-002)
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