THURSDAY PLANTATION - tea tree antiseptic ointment 
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 5% ...... Antiseptic

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

For external use only.

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

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

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

Antiseptic

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

store below 86 degrees F.

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


Tea Tree Antiseptic Ointment Label


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

THURSDAY PLANTATION 
tea tree antiseptic ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66141-644
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL3 g  in 50 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66141-644-5550 g in 1 JAR
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: bbe03f6e-37db-49c2-8930-77727aba77bf
Set id: 13902ab8-8562-4527-8ff9-82075002a41a
Version: 2
Effective Time: 20100218
 
Integria Healthcare Ballina