Label: JASON COOLING MINERALS AND TEA TREE PAIN THERAPY- methyl salicylate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 29, 2012

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  • ACTIVE INGREDIENT

    Methyl Salicylate                                  13.5%



  • PURPOSE

    Pain Reliver

  • INDICATIONS & USAGE

    • Helps relieve pain from injury or strain
  • WARNINGS

    For external use only. Keep out of reach of children. Do not apply heat, wrap or bandage to treated area. Avoid contact with eyes. Do not apply to open wound or irritated skin area. Do not use more than seven days continuously. Should contact with eyes occurs, rinse with cool water to remove. If pain does not go away or rash or irritation occurs, stop use and contact a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

  • DOSAGE & ADMINISTRATION


     Massage a small amount into affected area. Use only as directed. Adult and children 12 years of age and older: Apply generously and gentle massage until balm disappeared. Repeat 3 to 4 times daily. Children under 2 years of age ask a doctor.
  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil (1), Carthamus Tinctorius (Safflower) Seed Oil (1), Beeswax (1), Cetearyl Alcohol, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Tribehenin, Menthol, Polysorbate 60, Malaleuca Alternifolia (Tea Tree) Oil(1), Corylus Avellana (Hazelnut) Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycine Soja (Soybean) Oil (1), Oenothera Biennis (Evening Primrose) Oil, Olea Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame)  Seed Oil (1), Tocopheryl Acetate.

    (1) Certified Organic Ingredients
  • QUESTIONS

    Questions? Visit  www.jason-natural.com or call 1-877-527-Jason-01weekdays from 7am-5pm MST.

  • PRINCIPAL DISPLAY PANEL

    image of jar label

  • INGREDIENTS AND APPEARANCE
    JASON COOLING MINERALS AND TEA TREE PAIN THERAPY 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE13.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SESAME OIL (UNII: QX10HYY4QV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0602-8227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34809/23/2011
    Labeler - The Hain Celestial Group, Inc (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc858894996manufacture
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