MUSCLE AND JOINT HEAT CREAM- eucalyptus oil and tea tree oil cream 
Ultra Mix (Aust) Pty Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Muscle and Joint  Heat Cream

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

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

Product Carton Label

heat-cream

MUSCLE AND JOINT HEAT CREAM 
eucalyptus oil and tea tree oil cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL38.6 mg  in 1 g
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL42.5 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69594-003-01100 g in 1 TUBE; Type 0: Not a Combination Product02/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/2015
Labeler - Ultra Mix (Aust) Pty Ltd (752254649)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-003)

Revised: 4/2016
Document Id: a426dd55-6c88-40c1-87cb-e98c9cc3cc53
Set id: 0a452a0b-6dea-4a03-b7ea-fec440f83c29
Version: 3
Effective Time: 20160408
 
Ultra Mix (Aust) Pty Ltd