Label: PAIN RELEASE- menthol oil

  • NDC Code(s): 69204-007-03, 69204-007-04, 69204-007-05
  • 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 13, 2018

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  • SPL UNCLASSIFIED SECTION

    IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION. 

  • 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. 

  • 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 in Canada

  • Pain Release 30 ml

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

    SKU 10301

  • Pain Release 10 ml

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

    SKU 431201

  • Pain Release 6 ml

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

    SKU 442501

  • Pain Release Topical Analgesic Oil Blend 30 ml

    Saje® Natural Wellness

    Pain Release

    Topical Analgesic Oil Blend

    1 fl. oz. | 30 ml

    image description

  • Pain Release Topical Analgesic Oil Blend 10 ml

    Saje® Natural Wellness

    Pain Release

    Topical Analgesic Oil Blend

    0.34 fl. oz. | 10 ml

    image description

  • Pain Release Topical Analgesic Oil Blend 6 ml

    Saje® Natural Wellness

    Pain Release

    Topical Analgesic Oil Blend

    0.2 fl. oz. | 6 ml

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-007
    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
    1NDC:69204-007-031 in 1 BOX10/16/2016
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69204-007-041 in 1 BOX10/16/2016
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:69204-007-051 in 1 BOX10/16/2016
    36 mL in 1 BOTTLE, DROPPER; 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 - Natures Formulae Health Products Ltd. (241385587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(69204-007)
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