THURSDAY PLANTATION - tea tree antiseptic oil 
Integria Healthcare Ballina

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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Melaleuca Alternifolia (Tea Tree) Leaf Oil 100% ...... Antiseptic

Uses:  treats minor cuts, minor burns, scrapes, abrasions, insect bites and stings.

For external use only.

Avoid contact with eyes, mouth, ears or other sensitive areas of the body.  If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Antiseptic

Directions:  apply to the affected area.  Use sparingly by drop.  Children under 12 years of age:  consult a doctor.

store below 86 degrees F.

Thursday Plantation

Australia's Original

Tea Tree Antiseptic

100% Pure

Minimum 36% Terpinen-4-ol


Distributed By:
Integria Healthcare Australia
Pty Ltd 8 Clunies Ross Court
Eight Mile Plains, QLD 4113
Australia
www.thursdayplantation.com
USA Phone: 1-866-273-0377
Made in Australia

Tea Tree Antiseptic Oil 50 ml

THURSDAY PLANTATION 
tea tree antiseptic oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66141-641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AUSTRALIAN TEA TREE OIL (UNII: VIF565UC2G) (AUSTRALIAN TEA TREE OIL - UNII:VIF565UC2G) AUSTRALIAN TEA TREE OIL50 mL  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66141-641-0550 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/2010
Labeler - Integria Healthcare Ballina (750660367)
Registrant - Integria Healthcare Australia (741396386)
Establishment
NameAddressID/FEIBusiness Operations
Integria Healthcare Ballina750660367manufacture
Establishment
NameAddressID/FEIBusiness Operations
Integria Healthcare Australia741396386relabel

Revised: 2/2010
Document Id: f8b79c4b-e6fa-44f9-89d9-67bddda77289
Set id: 84ad50a1-ffa6-4f09-9234-fe70af1518d3
Version: 1
Effective Time: 20100215
 
Integria Healthcare Ballina