Label: ROLLING FARMACY- menthol kit

  • NDC Code(s): 70983-015-17
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    The need for wellness doesn't stop when you're on the go.  Keep this convenient collection of three of our favourit roll-ons close at hand, wherever your journey takes you.  Keep on rolling.

    Kit Contains 3 Saje Favorites:

    FORTIFY antitussive (cough suppressant) oil blend rub

    peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD

    gutzy SOOTHING BELLY MASSAGE BLEND

    IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

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

    LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL OIL BLENDS

    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 

    We support recycling. Please recycle where possible

    GET READY FOR WELLNESS

    SKU 22250301

  • 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

  • SOOTHING OIL BLENDS PEPPERMINT HALO cooling & soothing oil blend for the head

    Apply to the following areas:

    A - Along hairline

    B - Neck

    C - Shoulders

    Directions for use: Apply as desired to entire hairline, creating a halo effect. Apply to neck and shoulders for extra cooling and relaxation. Avoid eyes and mucous membranes. For prolonged use, consult a doctor.

    Ingredients: Mentha piperita (peppermint) oil, eucalyptus globulus leaf oil, melaleuca leucadendron cajaput oil, rosmarinus officinalis (rosemary) leaf oil, lavandula angustifolia (lavender) oil, and vetiveria zizanoides root oil.

    Warnings:

    • Keep out of reach of children.
    • For external use only. if swallowed, seek urgent care/call poison control.
    • If skin sensitization occurs, rinse with vegetable oil.
    • Avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil.
    • Do not use if pregnant/breastfeeding, with high/low blood pressure, or if epileptic.
    • If allergic reaction occurs, stop use & consult a doctor.
  • GUTZY soothing belly massage blend

    Apply to the following areas:

    A - Stomach

    Directions for use: Treat your tummy to an aromatic massage with soothing and comforting peppermint, fennel, chamomile, and black pepper. apply directly onto stomach, as desired, and massage in gently. For prolonged use, consult a doctor.

    Ingredients: vitis vinifera (grape) seed oil, foeniculum vulgare (fennel) oil, mentha piperita (peppermint) oil, anthemis nobilis flower oil, piper nigrum (pepper) seed oil, and commiphora myrrha oil.

    Warnings:

    • Keep out of reach of children.
    • For external use only. if swallowed, seek urgent care/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 commited to providing 100% natural products containing pure essentail 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, presevatives, fragrances or colors. 

  • PRINCIPAL DISPLAY PANEL

    Saje® Natural Wellness

    ROLLING FARMACY

    oil blend convenience kit

    1 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUB 0.34 FL.OZ. | 10 mL

    2 OIL BLENDS X 0.34 FL.OZ. | 10 mL EA 

    Rolling Farmacy Kit

  • INGREDIENTS AND APPEARANCE
    ROLLING FARMACY 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-015
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-015-171 in 1 KIT10/16/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 10 mL
    Part 21 BOTTLE, DROPPER 10 mL
    Part 31 BOTTLE, DROPPER 10 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
    110 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 DrugM01210/16/2016
    Part 2 of 3
    PEPPERMINT HALO 
    other fragrance preparations [fragrance preparations]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGREUCALYPTUS OIL (UNII: 2R04ONI662)  
    INGRCAJUPUT OIL (UNII: J3TO6BUQ37)  
    INGRROSEMARY OIL (UNII: 8LGU7VM393)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRVETIVER OIL (UNII: 9M9P32M01L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 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
    Part 3 of 3
    GUTZY 
    other fragrance preparations [fragrance preparations]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGRAPE SEED OIL (UNII: 930MLC8XGG)  
    INGRFENNEL OIL (UNII: 59AAO5F6HT)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRCHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    INGRBLACK PEPPER OIL (UNII: U17J84S19Z)  
    INGRMYRRH OIL (UNII: H74221J5J4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 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 DrugM01210/16/2016
    Labeler - Saje Natural Business Inc. (080465432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(70983-015)