MUSCLE AND JOINT HEAT CREAM- eucalyptus oil and tea tree oil cream

Muscle and Joint Heat Cream by

Drug Labeling and Warnings

Muscle and Joint Heat Cream by is a Otc medication manufactured, distributed, or labeled by Ultra Mix (Aust) Pty Ltd , Ultra Mix (Aust) Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives

Tea Tree Oil (Melaleuca Alternifolia) - 42.5 mg/g
Eucalyptus Oil (Eucalyptus radiata ) - 38.6 mg/g

Winter Green  Oil (Methyl Salicylate)- 50 mg/g

Purpose

Pain relief cream to assist with relief of joint and muscle pain

INACTIVE INGREDIENT

Indication and Usage

For the temporary relief of muscle andjoint aches and pains, includingsymptomatic relief of lower back pains.

May also assist with increased jointmobility & reduce inflammation andswelling of affected areas.

Contains phenoxyethanol as a preservative.

Dosage and Administration

Apply a small amount of Muscle and Joint Heat Cream to the affected area and massage in until fully absorbed. Use twice

daily or more frequently if required.

Warnings

For external use only.

Ensure safety seal is intact beforeopening. Keep tube sealed when not being used. Store below 300 C (86 F).

Keep out of reach from Children

KEEP OUT OF REACH OF CHILDREN

Product Carton Label

INGREDIENTS AND APPEARANCE

MUSCLE AND JOINT HEAT CREAM 
eucalyptus oil and tea tree oil cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69594-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	38.6 mg  in 1 g
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	42.5 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69594-003-01	100 g in 1 TUBE; Type 0: Not a Combination Product	02/16/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/16/2015

Labeler - Ultra Mix (Aust) Pty Ltd (752254649)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Mix (Aust) Pty Ltd		752254649	manufacture(69594-003)