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

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PAIN RELEASE (MENTHOL) LIQUID [SAJE NATURAL BUSINESS INC.]
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NDC 70983-005-08
Set ID a32b0950-3467-4e37-988d-104836af5971
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 0.25%

  • 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 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 water.

  • Questions?

    1-877-275-7253

  • SPL UNCLASSIFIED SECTION

    Distributed by: SAJE NATURAL WELLNESS 22 East 5th Ave Vancouver, BC Canada V5T 1G8 | saje.com | 1-877-275-7253 | Made by our friends in Canada

    DO NOT USE IF SECURITY SEAL AROUND CAP AND BOTTLE'S NECK IS BROKEN OR MISSING

    SKU 376701

  • DISPOSAL AND WASTE HANDLING

    We support recycling. Please recycle where possible.

  • Pain Release Topical Analgesic Mist (100 ml)

    Saje® Natural Wellness

    Pain Release

    Topical Analgesic Mist

    3.4 fl. oz. | 100 ml

    Pain Release Mist 100 mL

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70983-005
    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
    1NDC:70983-005-081 in 1 BOX10/16/2016
    1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    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(70983-005)
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