Label: PAIN RELEASE- menthol kit

  • NDC Code(s): 70983-010-12
  • Packager: Saje Natural Business Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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

  • SPL UNCLASSIFIED SECTION

    GET READY FOR WELLNESS

    Experience relief from muscular and joint aches from backache, arthritis, sprains and strains with this pain-relieving convenience kit.  Includes our popular roll-on oil blend, mist, massage oil, and bath salts.  Everything you need to feel better naturally. No pain, all gain. 

    Kit Contains 4 Saje Favorites:

    PAIN RELEASE topical analgesic oil blend

    PAIN RELEASE topical analgesic massage oil

    PAIN RELEASE topical analgesic mist

    PAIN RELEASE topical analgesic bath salt soak

    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 ANY OF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING:
    SEAL AROUND BOTTLE (OIL BLEND & MASSAGE OIL) | SEAL AROUND BOTTLE'S CAP AND NECK (MIST) | TEAR NOTCH ON ZIPPERED BAG INSIDE (SALTS)

    Distributed by: SAJE NATURAL WELLNESS | 500 - 88 East 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 22250701

    Lift here to continue to read important product information on all products.

  • 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 breastfeeding,

    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 and joints experiencing minor aches and pains, as directed: 

    A - Shoulders

    B - Neck

    C - Back

    D - Elbows

    E - Hands

    F - Soles of feet

    G - Hips

    H - Thighs

    I - Knees

    J - Calves

  • PAIN RELEASE topical analgesic massage oil  Drug Facts Active ingredient 

    Menthol 1.37%

  • 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 awa y.  

  • Directions

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

          not more than 3 to 4 times daily

    • Children under 12 years of age: Consult a doctor.
  • Inactive ingredients

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

  • PAIN RELEASE topical analgesic mist  Drug Facts Active ingredient 

    Menthol 0.25%

  • PURPOSE

    Purpose Topical Analgesic

    Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites

  • Warnings

    For external use only.

  • Do not use 

    • if epileptic
    • with high blood pressure
  • When using this product,

    avoid contact with the eyes.

  • 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 breastfeeding,

    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

    • Children under 12 years of age: Consult a doctor. 
  • 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 water.

  • PAIN RELEASE pain relieving bath salt soak  Drug Facts Active ingredient 

    Menthol 0.16%

  • PURPOSE

    Purpose External Analgesic

    Uses For the temporary relief of pain and itching associated with scrapes, insect bites, and minor skin irritations. 

  • Warnings

    For external use only.

  • Do not use

    • if epileptic
    • with high blood pressure
  • When using this product,

    avoid contact with the eyes.

  • 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

          by dissolving 2 teaspoons of salt soak in warm water and soaking area not more than 3 to 4 times daily.

    • Children under 12 years of age: Consult a doctor.
  • Inactive ingredients

    Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

  • PRINCIPAL DISPLAY PANEL

    Saje Natural Wellness

    PAIN RELEASE KIT

    topical analgesic convenience kit

    1 TOPICAL ANALGESIC OIL BLEND 0.34 FL.OZ. | 10 mL

    1 TOPICAL ANALGESIC MASSAGE OIL 1.4 FL.OZ. | 40 mL

    1 TOPICAL ANALGESIC MIST 1 FL.OZ. | 30 mL

    1 TOPICAL ANALGESIC BATH SALT SOAK NET WT. 4.2 OZ. | 120 g

    PAIN RELEASE KIT BOX

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-010
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70983-010-121 in 1 KIT10/16/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 10 mL
    Part 21 BOTTLE, DROPPER 40 mL
    Part 31 BOTTLE, SPRAY 30 mL
    Part 41 POUCH 120 g
    Part 1 of 4
    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
    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 DrugM01710/16/2016
    Part 2 of 4
    PAIN RELEASE 
    menthol oil
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.19 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)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeFREEFORM (oil) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    140 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 DrugM01710/16/2016
    Part 3 of 4
    PAIN RELEASE 
    menthol liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.23 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)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeFREEFORM (liquid) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/16/2016
    Part 4 of 4
    PAIN RELEASE 
    menthol granule
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SEA SALT (UNII: 87GE52P74G)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 PACKAGE
    1120 g in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/16/2016
    Labeler - Saje Natural Business Inc. (080465432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(70983-010)