PAIN RELEASE (MENTHOL) GRANULE [SAJE NATURAL BUSINESS INC.]

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PAIN RELEASE (MENTHOL) GRANULE [SAJE NATURAL BUSINESS INC.]
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NDC 70983-004-06, 70983-004-07
Set ID 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40
Category HUMAN OTC DRUG LABEL
Packager Saje Natural Business Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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 by dissolving 2 teaspoons of salt soak in warm water and soaking 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, 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.

  • QUESTIONS

    Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made in Canada

  • Pain Release 620 g

    DO NOT USE IF SAJE SEAL ON BOTTLE'S OPENING IS BROKEN OR MISSING.

    SKU 427901

  • Pain Release 120 g

    DO NOT USE IF TEAR NOTCH SECURITY SEAL ON ZIPPERED BAG INSIDE IS DAMAGED OR MISSING

    SKU 423501

  • Pain Release Bath Salt Soak 120 g

    Saje Natural Wellness

    Pain Release

    Pain Relieving Bath Salt Soak

    net wt. 4.2 oz. | 120 g

    image description

  • Pain Release Bath Salt Soak 620 g

    Saje® Natural Wellness

    Pain Release

    Pain Relieving Bath Salt Soak

    net wt. 21.9 oz. | 620 g

    image description

  • Pain Release Pain Relieving Bath Salt Soak net wt. 10.6 oz. | 300 g

    Saje Natural Wellness

    Pain Release

    Pain Relieving Bath Salt Soak

    net wt. 10.6 oz. | 300 g PAINRELEASE_300g_Bath Salt_Tub_705607_USA_FINAL.jpeg

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-004
    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
    1NDC:70983-004-06620 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2016
    2NDC:70983-004-071 in 1 PACKET10/16/2016
    2120 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70983-004-05300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
    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(70983-004)
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