Label: COMPLETE FORTIFY- menthol kit

  • NDC Code(s): 70983-018-20
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 12, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    GET READY FOR WELLNESS

    TAKE THE PLANT-BASED COMPLETE FORTIFY CONVENIENCE KIT WITH YOU WHEN YOU ARE TRAVELLING OR ON-THE-GO

    KIT CONTAINS 3 FORTIFYING FAVORITES:

    FORTIFY antitussive (cough suppressant) oil blend rub

    echinacea HERBAL SPRAY SUPPLEMENT

    fortified warmth RESTORATIVE BATH SALTS SOAK

    IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

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

    LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

    DO NOT USE IF ANY OF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING: SEAL AROUND BOTTLE (OIL BLEND) | SEAL AROUND BOTTE'S CAP AND NECK (SPRAY) | TEAR NOTCH ON ZIPPERED BAG INSIDE (SALTS)

    We support recycling. Please recycle where possible.

    SKU 22250801

  • FORTIFY antitussive (cough suppressant) oil blend rub 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 that by mouth or place in nostrils.

    Flammable.  Keep away from fire or flame

  • Do not use

    • if epileptic
    • with high blood pressure
  • Ask 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 or older: 
    • rub on throat and chest in a  thick layer
    • cover with warm 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. 

  • HERBAL SPRAY SUPPLEMENT & FORTIFYING BATH SALTS ECHINACEA herbal spray supplement

    Supplement Facts

    Serving Size 7 sprays (0.03 fl. oz. | 0.98 ml)

    Servings Per Container 30

    ----

    Amount per serving

    Fresh Echinacea purpurea (flower) 427 mg

    Licorice (root) 70 mg

    Fresh Echinacea angustifolia (root) 14 mg

    Elecampane (root) 14 mg

    Usnea (lichen) 14 mg

    Neem (leaf) 3.5 mg

    Southern Prickly Ash (Bark) 3.5 mg

    ---

    Daily Value (DV) not established

    OTHER INGREDIENTS: PURIFIED WATER, ETHANOL (45-50%)

    DIRECTIONS FOR USE: SHAKE WELL BEFORE USE.  TAKE 7 SPRAYS BY MOUTH EVERY 2 HOURS, 6 TIMES PER DAY.  CONSULT A HEALTH CARE PRACTITIONER FOR USE BEYOND 4-6 WEEKS.

  • WARNINGS

    WARNINGS: KEEP OUT OF REACH OF CHILDREN.  NOT RECOMMENDED FOR CHILDREN UNDER 12. 

    CONSULT A DOCTOR BEFORE USE: 

    • WITH MEDICATIONS OR BLEEDING OR BLEEDING DISORDERS
    • IF SYMPTOMS PERSIST/WORSEN

    DO NOT USE: 

    • WHILE TRYING TO CONCEIVE, OR WHILE PREGNANT/BREASTFEEDING. 
    • WHILE TAKING INSULIN, ORAL DIABETIC MEDICATIONS, GINSENG, OR OTHER MEDICATIONS / HERBS THAT MAY LOWER BLOOD SUGAR
    • WITH TUBERCULOSIS, LEUKOSIS, COLLAGENOSIS, MS, HIV/AIDS, AUTOIMMUNE DISORDERS, OR OTHER PROGRESSING SYSTEMIC DISEASES
    • IF TAKING MEDICATIONS THAT MAY AGGRAVATE ELECTORLYTE IMBALANCE, INCLUDING DIURETICS, CARDIAC GLYCOSIDES, AND CORTICOSTEROIDS
    • WITH HYPERTONIA (MUSCULAR RIGITDITY, TENSION, AND SPASMS), HYPERKALEMIA (EXCESSIVE POTASSIUM IN THE BLOOD) HIGH BLOOD PRESSURE, HEART DISORDERS, OR SEVERE OBESITY
    • WITH KIDNEY, LIVER, OR BILE FLOW DISORDERS. MAY CAUSE LIVER OR KIDNEY DAMAGE; DISCUSS SIDE EFFECTS WITH YOUR DOCTOR
    • IF ALLERGIC TO PLANTS OF THE ASTERACEAECOMPOSITAE/DAISY FAMILY.

    STOP USE IF ALLERGIC REACTION OCCURS

    CONTAINS NATURALLY OCCURING GLYCYRRHIZIN FROM LICORICE ROOT.  OVERCONSUMPTION OF GLYCYRRHIZIN FROM LICORICE ROOT CAN CAUSE BODY'S POTASSIUM LEVELS TO FALL, POSSIBLY RESULTING IN ABNORMAL HEART RHYTHMS/HIGH BLOOD PRESSURE/EDEMA (SWELLING)/LETHARGY/CONGESTIVE HEART FAILURE. 

  • FORTIFIED WARMTH restorative bath salt soak 

    DIRECTIONS FOR USE: FOR A STRENGTHENING AND FORTIFYING BATH, ADD 2 TEASPOONS TO WATER & SWISH TO DISSOLVE. CLOSE THE DOOR TO KEEP THE PRECIOUS AROMAS IN & STAY IMMERSED FOR 20-30 MINUTES.  FOR PROLONGED USE, CONSULT A DOCTOR

    INGREDIENTS: SEA SALT, MAGNESIUM SULFATE, ZEA MAYS (CORN) STARCH, SODIUM BICARBONATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, PINUS SYLVESTRIS LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PELARGONIUM GRAVEOLENS OIL, EUCALYPTUS GLOBULUS LEAF OIL, MENTHA PIPERITA (PEPPERMINT) OIL, AND CINNAMOMUM ZEYLANICUM LEAF OIL

    WARNINGS: KEEP OUT OF REACH OF CHILDREN.  FOR EXTERNAL USE ONLY.  IF SWALLOWED, SEEK URGENT CARE OR CALL POISON CONTROL.  AVOID EYES & MUCOUS MEMBRANES;  IF CONTACT OCCURS, RINSE WITH VEGETABLE OIL.  DO NOT USE IF PREGNANT/BREASTFEEDING OR IF EPILEPTIC.  IF ALLERGIC REACTION OCCURS, STOP USE & CONSULT A DOCTOR

  • SPL UNCLASSIFIED SECTION

    SAJE IS COMMITTED TO PROVIDING 100% NATURAL PRODUCTS, CONTAINING PURE ESSENTIAL OILS AND INGREDIENTS DERIVED FROM MINERAL AND BOTANICAL SOURCES. SAJE PRODUCTS ARE NOT TESTED ON ANIMALS AND DO NOT CONTAIN ANY ARTIFICIAL OR SYNTHETIC CHEMICALS, PRESERVATIVES, FRAGRANCES OR COLORS.

  • PRINCIPAL DISPLAY PANEL

    Saje® Natural Wellness

    COMPLETE FORTIFY
    restorative convenience kit

    1 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUB 0.2 FL. OZ. | 6 mL 

    1 HERBAL SUPPLEMENT SPRAY 1 FL. OZ. | 30 mL

    1 BATH SALTS ENVELOPE NET WT. 4.2 OZ. | 120 g

    complete fortify box

  • INGREDIENTS AND APPEARANCE
    COMPLETE FORTIFY 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-018
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-018-201 in 1 KIT01/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 6 mL
    Part 21 BOTTLE, SPRAY 30 mL
    Part 31 POUCH 120 g
    Part 1 of 3
    FORTIFY 
    menthol oil
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24.03 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
    16 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/16/2016
    Part 2 of 3
    ECHINACEA 
    herbal spray supplement tincture
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65) (ECHINACEA PURPUREA FLOWERING TOP - UNII:2EMS3QFX65) ECHINACEA PURPUREA FLOWERING TOP427 mg  in 0.98 mL
    LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE70 mg  in 0.98 mL
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) (ECHINACEA ANGUSTIFOLIA ROOT - UNII:D982V7VT3P) ECHINACEA ANGUSTIFOLIA ROOT14 mg  in 0.98 mL
    INULA HELENIUM ROOT (UNII: E55SMD6DA8) (INULA HELENIUM ROOT - UNII:E55SMD6DA8) INULA HELENIUM ROOT14 mg  in 0.98 mL
    USNEA BARBATA (UNII: D6DVA9TCAP) (USNEA BARBATA - UNII:D6DVA9TCAP) USNEA BARBATA14 mg  in 0.98 mL
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T) (AZADIRACHTA INDICA LEAF - UNII:HKY915780T) AZADIRACHTA INDICA LEAF3.5 mg  in 0.98 mL
    ZANTHOXYLUM CLAVA-HERCULIS WHOLE (UNII: Z5VZA25BUK) (ZANTHOXYLUM CLAVA-HERCULIS BARK - UNII:0QN10WG2A2) ZANTHOXYLUM CLAVA-HERCULIS WHOLE3.5 mg  in 0.98 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/01/2017
    Part 3 of 3
    FORTIFIED WARMTH 
    bath oils, tablets, and salts granule
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSEA SALT (UNII: 87GE52P74G)  
    INGRMAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    INGRSTARCH, CORN (UNII: O8232NY3SJ)  
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRPINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    INGRROSEMARY OIL (UNII: 8LGU7VM393)  
    INGRPELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    INGREUCALYPTUS OIL (UNII: 2R04ONI662)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRCINNAMON OIL (UNII: E5GY4I6YCZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1120 g in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2017
    Labeler - Saje Natural Business Inc. (203413380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(70983-018)