THURSDAY PLANTATION- tea tree antiseptic ointment

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 5% ...... Antiseptic

INDICATIONS & USAGE

Uses:  protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection.

WARNINGS

For external use only.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

STOP USE

Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.

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:  clean the affected area.  apply small amount two or three times a day.  may be covered with a sterile bandage. 

STORAGE AND HANDLING

store below 86 degrees F.

PRINCIPAL DISPLAY PANEL

Thursday Plantation

Australia's Original

Tea Tree Antiseptic

With Vitamin E

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

INACTIVE INGREDIENT

Inactive Ingredients:  Cetearyl Alcohol, Mineral Oil, Paraffin, Sodium Lauryl Sulfate, Tocopheryl Acetate (vitamin E).

INGREDIENTS AND APPEARANCE

THURSDAY PLANTATION 
tea tree antiseptic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66141-644
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	3 g  in 50 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66141-644-55	50 g in 1 JAR

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