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

Jason Cooling Minerals and Tea Tree Pain Therapy by

Drug Labeling and Warnings

Jason Cooling Minerals and Tea Tree Pain Therapy by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

JASON COOLING MINERALS AND TEA TREE PAIN THERAPY 
methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	13.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0602-8	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	09/23/2011

Labeler - The Hain Celestial Group, Inc (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc		858894996	manufacture