ELMORE OIL- eucalyptus oil and tea tree oil oil 
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.

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Elmore Oil

Actives

Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)
Eucalyptus Oil (Eucalyptus radiata ) - 3.86% (38.6 mg/ml)

Purpose

Massage Oil to assist with relief of joint and muscle pain

Indication and Usage

Temporary relief of joint and muscle pain, including lower back pain

Dosage and Administration

Apply a small amount of Elmore Oil to the pain affected area and gently massage in until fully absorbed. Use before and after activity for maximum relief.

Warnings

For external use only.
Keep out of reach of children

Product Label

elmore

ELMORE OIL 
eucalyptus oil and tea tree oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-002
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 mL
Tea Tree Oil (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) Tea Tree Oil42.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL (UNII: 6UYK2W1W1E)  
VANILLIN (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69594-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
2NDC:69594-002-02125 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
3NDC:69594-002-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2015
4NDC:69594-002-04300 mL in 1 BOTTLE; 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(69594-002)

Revised: 4/2016
Document Id: 46ac3eda-81c1-49e8-82c1-d01c9b6a09c8
Set id: b1b544d0-3a89-4c4c-8213-9549aeba8bbf
Version: 2
Effective Time: 20160405
 
Ultra Mix (Aust) Pty Ltd