Label: COMPLETE FORTIFY- menthol kit
- NDC Code(s): 70983-018-20
- Packager: Saje Natural Business Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 5, 2023
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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
- PURPOSE
- Warnings
- Do not use
- Ask doctor before use if you have
- When using this product, do not
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
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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
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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
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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.
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COMPLETE FORTIFY
menthol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-018 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70983-018-20 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 oilProduct 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 Drug M012 10/16/2016 Part 2 of 3 ECHINACEA
herbal spray supplement tinctureProduct 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 granuleProduct 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 Drug M012 01/01/2017 Labeler - Saje Natural Business Inc. (080465432) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(70983-018)