Label: COMFORT AND EASE- menthol kit

  • NDC Code(s): 70983-016-18
  • 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 October 11, 2016

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

  • SPL UNCLASSIFIED SECTION

    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

    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. 

  • 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

    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

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
    • epilepsy
  • 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. 
    • sun tan/use tanning beds for 3-4 days after use
  • 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

    • See important warnings under 'When using this product'
    • Adults and children 12 years and older: 
    • rub on the throat and chest in a thick layer
    • cover with a warm, dry 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

    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

  • PRINCIPAL DISPLAY PANEL

    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

  • INGREDIENTS AND APPEARANCE
    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)