Label: PAIN RELEASE- menthol oil

  • NDC Code(s): 69204-008-10, 69204-008-11
  • Packager: Natures Formulae Health Products Ltd.
  • 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 16, 2016

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  • DRUG FACTS Active ingredient

    Menthol 1.37%

  • PURPOSE

    Purpose Topical Analgesic

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

    • 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.

  • Questions?

    1-877-275-7253

  • SPL UNCLASSIFIED SECTION

    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

    DO NOT USE IF SECURITY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

    SKU 415401

  • DISPOSAL AND WASTE HANDLING

    We support recycling.  Please recycle where possible. 

  • Pain Release Topical Analgesic Massage Oil

    Saje® Natural Wellness

    Pain Release

    Topical Analgesic Massage Oil

    6.8 fl. oz. | 200 ml and 1.4 fl.oz | 40ml

    Pain release 40ml massage oil label

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.18 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
    1NDC:69204-008-101 in 1 BOX10/16/2016
    1200 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69204-008-1140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/16/2016
    Labeler - Natures Formulae Health Products Ltd. (241385587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(69204-008)
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