Label: PAIN RELEASE- menthol granule

  • NDC Code(s): 69204-005-06, 69204-005-07
  • 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 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 620 g

    Saje® Natural Wellness

    Pain Release 

    Pain Relieving Bath Salt Soak

    net wt. 21.9 oz. | 620 g

    image description

  • 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

  • INGREDIENTS AND APPEARANCE
    PAIN RELEASE 
    menthol granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69204-005
    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:69204-005-06620 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2016
    2NDC:69204-005-071 in 1 PACKET10/16/2016
    2120 g in 1 POUCH; 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(69204-005)
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