Complete Fortify: Package Insert and Label Information

COMPLETE FORTIFY- menthol
Saje Natural Business Inc.

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.

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 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
  • 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: 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

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.

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
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Fortified Warmth Bath Oils, Tablets, and Salts
COMPLETE FORTIFY
menthol kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-018
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70983-018-20 1 KIT in 1 KIT None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 24.03 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CINNAMON OIL
EUCALYPTUS OIL
TEA TREE OIL
PELARGONIUM GRAVEOLENS FLOWER OIL
PEPPERMINT OIL
PINE NEEDLE OIL (PINUS SYLVESTRIS)
ROSEMARY OIL
GRAPE SEED OIL
Product Characteristics
Color white (clear) Score
Shape FREEFORM (oil) Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 6 mL in 1 BOTTLE, DROPPER None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECHINACEA PURPUREA FLOWERING TOP (ECHINACEA PURPUREA FLOWERING TOP) ECHINACEA PURPUREA FLOWERING TOP 427 mg in 0.98 mL
LICORICE (LICORICE) LICORICE 70 mg in 0.98 mL
ECHINACEA ANGUSTIFOLIA ROOT (ECHINACEA ANGUSTIFOLIA ROOT) ECHINACEA ANGUSTIFOLIA ROOT 14 mg in 0.98 mL
INULA HELENIUM ROOT (INULA HELENIUM ROOT) INULA HELENIUM ROOT 14 mg in 0.98 mL
USNEA BARBATA (USNEA BARBATA) USNEA BARBATA 14 mg in 0.98 mL
AZADIRACHTA INDICA LEAF (AZADIRACHTA INDICA LEAF) AZADIRACHTA INDICA LEAF 3.5 mg in 0.98 mL
ZANTHOXYLUM CLAVA-HERCULIS WHOLE (ZANTHOXYLUM CLAVA-HERCULIS BARK) ZANTHOXYLUM CLAVA-HERCULIS WHOLE 3.5 mg in 0.98 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 30 mL in 1 BOTTLE, SPRAY None
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
granule
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
SEA SALT
MAGNESIUM SULFATE, UNSPECIFIED FORM
STARCH, CORN
SODIUM BICARBONATE
TEA TREE OIL
PINE NEEDLE OIL (PINUS SYLVESTRIS)
ROSEMARY OIL
PELARGONIUM GRAVEOLENS FLOWER OIL
EUCALYPTUS OIL
PEPPERMINT OIL
CINNAMON OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 120 g in 1 POUCH None
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 — Saje Natural Business Inc. (203413380)
Establishment
Name Address ID/FEI Operations
Natures Formulae Health Products Ltd. 241385587 manufacture (70983-018)

Revised: 11/2022 Saje Natural Business Inc.

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