Bio Bute: Product Information

By Medivet Pty Ltd | Last revised: 7 September 2012

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.

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

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

(click image for full-size original)

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (TEA TREE OIL)	TEA TREE OIL	42.5 mg in 1 mL
EUCALYPTUS OIL (EUCALYPTUS OIL)	EUCALYPTUS OIL	38.6 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Olive Oil

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51083-100-00	125 mL in 1 BOTTLE, PLASTIC	None
2	NDC:51083-100-01	500 mL in 1 BOTTLE, PLASTIC	None

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	Operations
Elmore Oil Company Pty Ltd		755881968	manufacture, analysis, api manufacture

Revised: 09/2012 Medivet Pty Ltd