Bio Bute: Product Information

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
biobute
(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

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