ELMORE OIL- tea tree oil and eucalyptus oil oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Elmore Oil Company Pty Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Massage Oil to assist with relief of joint and muscle pain

Authorization status:

unapproved drug other

Summary of Product characteristics

ELMORE OIL- TEA TREE OIL AND EUCALYPTUS OIL OIL
ELMORE OIL COMPANY 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._
----------
ACTIVE INGREDIENTS
Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)
Eucalyptus Oil (E. Polybractea) - 3.86% (38.6 mg/ml)
PURPOS E
Massage Oil to assist with relief of joint and muscle pain
INDICATION AND USAGE
Temporary relief of joint and muscle pain, including lower back pain
DOSAGE AND ADMINISTRATION
Apply a small amount of Elmore Oil to the pain affected area and
gently massage in until fully absorbed.
Use before and after activity for maximum relief.
WARNINGS
For external use only.
In case of accidental ingestion, get medical help or contact a Poisons
Control Center right away.
INACTIVE INGREDIENTS
Olive Oil (INCI name: Olea Europaea (Olive)
Vanilla (INCI Name: Vanillin)
KEEP OUT OF REACH OF CHILDREN
Keep Out of Reach of Children
PRODUCT LABEL
Elmore Oil Company Pty Ltd
ELMORE OIL
tea tree oil and eucalyptus oil oil
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:439 79 -439
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:439 79 -439 -0 3
50 mL in 1 BOTTLE, PLASTIC
2
NDC:439 79 -439 -0 4
250 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 7/0 1/20 13
LABELER -
Elmore Oil Company Pty Ltd (755881968)
Revised: 4/2013