COMPLETE FORTIFY- menthol kit

Complete Fortify by

Drug Labeling and Warnings

Complete Fortify by is a Otc medication manufactured, distributed, or labeled by Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COMPLETE FORTIFY 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-019

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-019-20	1 in 1 KIT	01/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	6 mL
Part 2	1 BOTTLE, SPRAY	30 mL
Part 3	1 POUCH	120 g

Part 1 of 3

FORTIFY 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	24.03 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/16/2016

Part 2 of 3

ECHINACEA 
herbal spray supplement tincture

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65) (ECHINACEA PURPUREA FLOWERING TOP - UNII:2EMS3QFX65)	ECHINACEA PURPUREA FLOWERING TOP	427 mg  in 0.98 mL
LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883)	LICORICE	70 mg  in 0.98 mL
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) (ECHINACEA ANGUSTIFOLIA ROOT - UNII:D982V7VT3P)	ECHINACEA ANGUSTIFOLIA ROOT	14 mg  in 0.98 mL
INULA HELENIUM ROOT (UNII: E55SMD6DA8) (INULA HELENIUM ROOT - UNII:E55SMD6DA8)	INULA HELENIUM ROOT	14 mg  in 0.98 mL
USNEA BARBATA (UNII: D6DVA9TCAP) (USNEA BARBATA - UNII:D6DVA9TCAP)	USNEA BARBATA	14 mg  in 0.98 mL
AZADIRACHTA INDICA LEAF (UNII: HKY915780T) (AZADIRACHTA INDICA LEAF - UNII:HKY915780T)	AZADIRACHTA INDICA LEAF	3.5 mg  in 0.98 mL
ZANTHOXYLUM CLAVA-HERCULIS WHOLE (UNII: Z5VZA25BUK) (ZANTHOXYLUM CLAVA-HERCULIS BARK - UNII:0QN10WG2A2)	ZANTHOXYLUM CLAVA-HERCULIS WHOLE	3.5 mg  in 0.98 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/01/2017

Part 3 of 3

FORTIFIED WARMTH 
bath oils, tablets, and salts granule

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SEA SALT (UNII: 87GE52P74G)
INGR	MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
INGR	STARCH, CORN (UNII: O8232NY3SJ)
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
INGR	ROSEMARY OIL (UNII: 8LGU7VM393)
INGR	PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
INGR	EUCALYPTUS OIL (UNII: 2R04ONI662)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	CINNAMON OIL (UNII: E5GY4I6YCZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		120 g in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2017

Labeler - Natures Formulae Health Products Ltd. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-019)