OUT BACK PAIN RELIEF- eucalyptus oil and tea tree oil oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ultra Mix (Aust) 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

OUT BACK PAIN RELIEF- EUCALYPTUS OIL AND TEA TREE OIL OIL
ULTRA MIX (AUST) 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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OUT BACK PAIN RELIEF
ACTIVES
Tea Tree Oil (Melaleuca Alternifolia) - 4.25% (42.5 mg/ml)
Eucalyptus Oil (Eucalyptus radiata) - 3.86% (38.6 mg/ml)
INACTIVES
Olive oil and Vanilin
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.
If pregnant or breast feeding ask health care professional before use.
Keep out of reach from children.
KEETP OUT OF REACH OF CHILDREN
Keetp out of reach of children
PRODUCT LABEL
OUT BACK PAIN RELIEF
eucalyptus oil and tea tree oil oil
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 59 4-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) (EUCALYPTUS OIL - UNII:2R0 4ONI6
6 2)
EUCALYPTUS OIL
38 .6 mg in 1 mL
TEA TREE O IL (UNII: VIF56 5UC2G) (TEA TREE OIL - UNII:VIF56 5UC2G)
TEA TREE OIL
42.5 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
O LIVE O IL (UNII: 6 UYK2W1W1E)
VANILLIN (UNII: CHI530 446 X)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:6 9 59 4-0 0 1-0 1
30 0 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n
Pro duc t
0 2/16 /20 15
2
NDC:6 9 59 4-0 0 1-
0 2
50 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct
0 2/16 /20 15
Ultra Mix (Aust) Pty Ltd
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R O