THURSDAY PLANTATION- tea tree antiseptic oil

Thursday Plantation by

Drug Labeling and Warnings

Thursday Plantation by is a Otc medication manufactured, distributed, or labeled by Integria Healthcare Ballina, Integria Healthcare Australia. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

WARNINGS

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

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Antiseptic

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

store below 86 degrees F.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

THURSDAY PLANTATION 
tea tree antiseptic oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66141-640
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	25 mL  in 25 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66141-640-52	25 mL in 1 BOTTLE
2	NDC: 66141-640-01	10 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2010

Labeler - Integria Healthcare Ballina (750660367)

Registrant - Integria Healthcare Australia (741396386)

Establishment
Name	Address	ID/FEI	Business Operations
Integria Healthcare Ballina		750660367	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Integria Healthcare Australia		741396386	relabel