TEA TREE OIL ANTISEPTIC- melaleuca alternifolia (tea tree) leaf oil oil 
Integria Healthcare (Australia) Pty. Ltd.

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.

----------

Maelaleuca alternifolia (Tea Tree) Leaf Oil 100%

First Aid Antiseptic

First aid to help protect against infection in minor cuts, scrapes, and burns.

For external use only.

Do not

  • use near the eyes, mouth, ears or other sensitive areas of the body
  • if contact occurs, rinse thoroughly with water
  • apply over large areas of the body
  • longer than 1 week unless directed by a doctor.

Ask your doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

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

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

It is recommended you skin patch test prior to use.

  • clean the affected area
  • apply a small amount of this product on the area (sparingly by drop) 1 to 3 times daily
  • may be covered with a sterile bandage.

  • store below 86F/30C.
  • Do not use if plastic seal around cap is broken or missing
  • Keep carton.  It contains important information.

None.

MADE IN AUSTRALIA

Integria Healthcare (Australia) Pty Ltd.,

Building 5, Freeway Office Park, 2728 Logan Road,

Eight Mile Plains, QLD 4113 Australia

us.thursdayplantation.com

Questions or Comment?

CUTS & SCRAPS

Apply oil directly to cut or wound

MINOR BURNS

Gengly apply oil to minor burns

Bungawalbyn is the birthplace of Australia's Original Tea Tree Oil, Thursday Plantation.  The indigenous people of Australia used this oil and today its therapeutic benefits are acknowledged worldwide.

NDC 70446-640-02

Thursday

Plantation

Australia's Original

TEA TREE OIL

ANTISEPTIC

Minimum 40% Terpinen-4-ol

100% Pure

0.5 fl oz/15 mL

TeaTreeOilCarton

TEA TREE OIL ANTISEPTIC 
melaleuca alternifolia (tea tree) leaf oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70446-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL15 mL  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70446-640-021 in 1 CARTON08/16/2016
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70446-640-0325 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2016
3NDC:70446-640-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/16/201607/13/2020
Labeler - Integria Healthcare (Australia) Pty. Ltd. (741396386)
Establishment
NameAddressID/FEIBusiness Operations
Integria Healthcare (Ballina) Pty Ltd750660367manufacture(70446-640)

Revised: 7/2020
Document Id: aa5c207f-2da5-3a2e-e053-2a95a90abcf8
Set id: 173d3114-6c8a-4089-9e0b-92a8d0fa5b3b
Version: 5
Effective Time: 20200713
 
Integria Healthcare (Australia) Pty. Ltd.