THURSDAY PLANTATION - tea tree antiseptic cream cream 
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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Active Ingredient:  melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

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

Warnings:

For external use only

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 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 - if swallowed, get medical help or contact a Poison Control Center right away.

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

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

Thursday Plantation

Tea Tree Antiseptic Cream

Gently soothes and relieves

Tea Tree Antiseptic Cream Label

THURSDAY PLANTATION 
tea tree antiseptic cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66141-643
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 OIL5 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66141-643-50100 g in 1 TUBE
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: 568dd84f-a59f-4ce3-aaf6-6180045b8490
Set id: 94acf69b-6ddc-4c85-857b-4c61e197cba9
Version: 1
Effective Time: 20100208
 
Integria Healthcare Ballina