THURSDAY PLANTATION- tea tree antiseptic cream cream

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

Active Ingredient:  melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

INDICATIONS & USAGE

Uses:  minor burns, sunburn, minor skin irritations, scratches, dry skin, reduces inflammation

WARNINGS

Warnings:

For external use only

WHEN USING

When using this product - avoid contact with eyes, mouth, ears and 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 - in case of deep puncture wounds or serious burns, consult a doctor.

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.

DOSAGE & ADMINISTRATION

Directions - apply to the affected areas as often as needed.

DESCRIPTION

Other Information - store below 86 degrees F.

Integria Healthcare Australia Pty Ltd
8 Clunies Ross Court, Eight Mile Plains
QLD 4113 Australia
www.thursdayplantation.com

Distributed by:
USA: Integria Healthcare (Australia) Pty Ltd.
PO Box 4854, Eight Mile Plains
QLD 4113 Australia
USA Phone: 1-866-273-0377

INACTIVE INGREDIENT

Inactive Ingredients:  Bentonite, Cetyl Alcohol, Glycerin, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Sodium Hydroxymethylglycinate, Sodium Stearoyl Lactylate, Water, Xantham Gum.

PRINCIPAL DISPLAY PANEL

Thursday Plantation

Tea Tree Antiseptic Cream

Gently soothes and relieves

INGREDIENTS AND APPEARANCE

THURSDAY PLANTATION 
tea tree antiseptic cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66141-643
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AUSTRALIAN TEA TREE OIL (UNII: VIF565UC2G) (AUSTRALIAN TEA TREE OIL - UNII:VIF565UC2G)	AUSTRALIAN TEA TREE OIL	5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66141-643-50	100 g in 1 TUBE

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