BIO BUTE- tea tree oil and eucalyptus oil oil

Bio Bute by

Drug Labeling and Warnings

Bio Bute by is a Animal medication manufactured, distributed, or labeled by Medivet Pty Ltd, Elmore Oil Company Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Uses

Massage Oil to assist with relief of joint and muscle pain

Warnings

For External and Animal Use Only

Keep Out of Reach of Children

Keep Out of Reach of Children. In case of accidental ingestion, get medical help or contact a Poisons Control Center right away

Inactive Ingredient Section

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

Package Label Principal Display Panel

For Animal Use Only

Store below 30 degrees C / 86 degrees F

Manufactured By Elmore Oil Company
1/70 Powells Av, VIC 3550 Australia.
For Medivet Veterinary Supplies
A4/101 Rookwood Road. Yagoan NSW 2199

INGREDIENTS AND APPEARANCE

BIO BUTE 
tea tree oil and eucalyptus oil oil

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51083-100(NDC:43979-400)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	42.5 mg  in 1 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	38.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Olive Oil (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51083-100-00	125 mL in 1 BOTTLE, PLASTIC
2	NDC: 51083-100-01	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/15/2012

Labeler - Medivet Pty Ltd (757292763)

Establishment
Name	Address	ID/FEI	Business Operations
Elmore Oil Company Pty Ltd		755881968	manufacture, analysis, api manufacture