COMFORT AND EASE- 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.

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Comfort and Ease Oil Blend Convenience Kit (3 x 6 ml)

GET READY FOR WELLNESS

Reach for this convenient trio of oil blends to support your wellness, naturally. 

Kit Contains 3 popular saje oil blends:

FORTIFY antitussive (cough suppressant) oil blend rub

SWEET COMFORT antitussive (cough suppressant) oil blend rub

inhale SOOTHING OIL BLEND FOR DEEP BREATHING

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 ALL OIL BLENDS

DO NOT USE IF SECURITY SEAL AROUND BOTTLES IS BROKEN OR MISSING.

We support recycling. Please recycle where possible

SKU 22250001

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

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, 

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

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. 

Fortify antitussive (cough suppressant) oil blend rub

Apply to the following areas, as directed:

A - Throat

B - Chest

SWEET COMFORT antitussive (cough suppressant) oil blend rub

Drug Facts

Active ingredient  

Menthol 2.76%

Purpose Antitussive (Cough Suppressant)

Uses Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. Suppresses your cough to help you get to sleep. 

Warnings

For external use only. Do not take by mouth or place in nostrils.

Flammable. Keep away from fire or flame. 

Ask doctor before use if you have

When using this product, do not

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 of 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

Other information

Inactive ingredients

Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, peppermint oil, pine needle oil, and prunus armeniaca (apricot) kernel oil

Sweet Comfort antitussive (cough suppressant) oil blend rub

Apply to the following areas, as directed: 

A - Throat

B - Chest

SOOTHING OIL BLEND

INHALE soothing oil blend for deep breathing

Directions for use: Used in aromatherapy to promote peaceful breaths. Apply to forehead and sinus areas, avoiding eyes and mucous membranes. Use on skin to soothe dry areas or add 10-20 drops to a bath. For prolonged use, consult a doctor.

Ingredients: Vitis vinifera (grape) seed oil, lavandula angustifolia (lavender) oil, citrus limon (lemon) peel oil, pelargonium graveolens oil, commiphora myrrha oil, mentha piperita (peppermint) oil, and anthemis nobilis flower oil.

Warnings: Keep out of reach of children. For external use only. if swallowed, seek urgent care/call poison control. If epileptic, consult a doctor before use. Avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. Do not use if pregnant/breastfeeding. If allergic reaction occurs, stop use & consult a doctor. Phototoxic; do not sun tan/use tanning beds for 3-4 days after use.

Apply to the following areas:

A - Forehead

B - Sinus Area

COMFORT & EASE
oil blend convenience kit

2 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUBS X 0.2 FL. OZ. | 6 mL EA

1 OIL BLEND 0.2 FL. OZ. | 6 mL

Saje® Natural Wellness

Comfort & Ease Box

COMFORT AND EASE 
menthol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-016
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70983-016-181 in 1 KIT10/16/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, DROPPER 6 mL
Part 21 BOTTLE, DROPPER 6 mL
Part 31 BOTTLE, DROPPER 6 mL
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
SWEET COMFORT 
menthol oil
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24.56 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL (UNII: I9GRO824LL)  
TEA TREE OIL (UNII: VIF565UC2G)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
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 3 of 3
INHALE 
other skin care preparations
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGRAPE SEED OIL (UNII: 930MLC8XGG)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRPELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
INGRMYRRH OIL (UNII: H74221J5J4)  
INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
INGRCHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
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
Cosmetic
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(70983-016)

Revised: 10/2016
Document Id: 0d5fdd1a-36c8-4103-89b3-0db0b55c9bb3
Set id: 97640f0c-0e8d-48ad-80a2-d3988962ded2
Version: 1
Effective Time: 20161011
 
Saje Natural Business Inc.