Label: ROAD TO WELLNESS- menthol kit

  • NDC Code(s): 70983-017-19
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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

    Kit Contains 3 SAJE FAVORITES:

    TRAUMA LESS topical analgesic ointment

    PAIN RELEASE topical analgesic oil blend

    peppermint halo COOLING & SOOTHING OIL BLEND FOR THE HEAD

    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 THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING:

    SEAL AROUND TIN (OINTMENT) | SEAL AROUND BOTTLE (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

    SKU 22280201

    LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON ALL PRODUCTS.

    GET READY FOR WELLNESS

  • Drug Facts Active ingredient 

    Menthol 1.27%

  • PURPOSE

    Purpose Topical analgesic

    Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • Do not use 

    • on wounds or damaged skin
    • if allergic to plants of the asteraceae/compositae/daisy family.
  • When using this product

    • avoid contact with the eyes
    • do not bandage tightly.
  • Stop use and ask a doctor

    if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • If pregnant or breast-feeding,

    ask a doctor before use.

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Apply to affected area 
  • DOSAGE & ADMINISTRATION

         not more than 3 times daily.

    • Not recommended for children under 12 years of age.
  • Inactive ingredients

    Arnica montana flower extract, beeswax (yellow), olive oil, and peppermint oil. 

  • PAIN RELEASE - topical analgesic oil blend Drug Facts Active ingredient 

    Menthol 1.98%

  • PURPOSE

    Purpose Topical Analgesic

    Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

  • Warnings

    For external use only. 

    Flammable. Keep away from fire or flame.

  • Do not use

    • on wounds or damaged skin
    • if epileptic
    • with high blood pressure
  • When using this product,

    • avoid contact with the eyes
    • do not bandage tightly
  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • 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

    • Adults and children 12 years of age and older: Apply to affected area
  • DOSAGE & ADMINISTRATION

         not more than 3 to 4 times daily

    • Not recommended for children under 12 years of age
  • Inactive ingredients

    Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

  • Pain Release - topical analgesic oil blend

    Apply to muscles & joints experiencing minor aches & pains, as directed:

    A - Shoulders

    B - Neck

    C - Back (upper/middle/lower)

    D - Elbows

    E - Hands

    F - Soles of Feet

    G - Hips

    H - Thighs

    I - Knees

    J - Calves

  • SOOTHING OIL BLEND 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.
  • SPL UNCLASSIFIED SECTION

    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. 

  • PRINCIPAL DISPLAY PANEL

    ROAD TO WELLNESS

    cooling relief convenience kit

    1 TOPICAL ANALGESIC OINTMENT 0.47 OZ. | 13.5 g

    1 TOPICAL ANALGESIC OIL BLEND 0.2 FL.OZ. | 6 mL

    1 OIL BLEND 0.2 FL.OZ. | 6 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ROAD TO WELLNESS 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-017
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-017-191 in 1 KIT10/16/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CANISTER 13.5 g
    Part 21 BOTTLE, DROPPER 6 mL
    Part 31 BOTTLE, DROPPER 6 mL
    Part 1 of 3
    TRAUMA LESS 
    menthol ointment
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    113.5 g in 1 CANISTER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/16/2016
    Part 2 of 3
    PAIN RELEASE 
    menthol oil
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL17.62 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    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 not finalpart34810/16/2016
    Part 3 of 3
    PEPPERMINT HALO 
    other skin care 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
    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 not finalpart34810/16/2016
    Labeler - Saje Natural Business Inc. (203413380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(70983-017)