BIO BUTE- tea tree oil and eucalyptus oil oil

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G), EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)

Commercializzato da:

Medivet Pty Ltd

Via di somministrazione:

TOPICAL

Tipo di ricetta:

OTC

Indicazioni terapeutiche:

Massage Oil to assist with relief of joint and muscle pain

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

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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ACTIVE INGREDIENT
Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)
Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)
US ES
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
BIO BUTE
tea tree oil and eucalyptus oil oil
PRODUCT INFORMATION
PRODUCT T YPE
OTC ANIMAL DRUG
ITE M CODE (SOURCE )
NDC:510 8 3-10 0 (NDC:439 79 -40 0 )
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TEA TREE O IL (UNII: VIF56 5UC2G) (TEA TREE OIL - UNII:VIF56 5UC2G)
TEA TREE OIL
42.5 mg in 1 mL
EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) (EUCALYPTUS OIL - UNII:2R0 4ONI6
6 2)
EUCALYPTUS OIL
38 .6 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
O LIVE O IL (UNII: 6 UYK2W1W1E)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:510 8 3-10 0 -0 0
125 mL in 1 BOTTLE, PLASTIC
2
NDC:510 8 3-10 0 -0 1
50 0 mL in 1 BOTTLE, PLASTIC
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 9 /15/20 12
LABELER -
Medivet Pty Ltd (757292763)
Medivet Pty Ltd
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Elmo re Oil Co mpany Pty Ltd
755