BIO BUTE  - tea tree oil and eucalyptus oil oil 
Medivet 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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Tea Tree Oil (Melaleuca Alternifolia)  -               4.25%    (42.5 mg/ml)
Eucalyptus Oil (E. Polybractea)        -              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

Warning

For external use only. In case of accidental ingestion, get medical help or contact a Poisons Control Center right away

Dosage and Administration

   Apply a small amount of Bio Bute to the pain affected area and gently massage in until fully absorbed

Inactive Ingredients

Olive Oil               (INCI name: Olea Europaea (Olive) Oil)
Vanilla                 (INCI Name: Vanillin)

Keep Out of reach of Children

Keep Out of reach of Children

biobute

BIO BUTE 
tea tree oil and eucalyptus oil oil
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51083-100(NDC:43979-400)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (TEA TREE OIL) TEA TREE OIL42.5 mg  in 1 mL
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL38.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Olive Oil 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:51083-100-00125 mL in 1 BOTTLE, PLASTICNone
2NDC:51083-100-01500 mL in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/20/2012

Labeler - Medivet Pty Ltd (757292763)
Establishment
NameAddressID/FEIOperations
Elmore Oil Company Pty Ltd755881968manufacture, analysis

Revised: 07/2012 Medivet Pty Ltd