TEA TREE OIL ANTISEPTIC (melaleuca alternifolia- tea tree leaf oil oil

Tea Tree Oil Antiseptic by

Drug Labeling and Warnings

Tea Tree Oil Antiseptic by is a Otc medication manufactured, distributed, or labeled by Integria Healthcare (Australia) Pty. Ltd., Integria Healthcare (Ballina) Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Maelaleuca alternifolia (Tea Tree) Leaf Oil 100%

PURPOSE

First Aid Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

• 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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

None.

DESCRIPTION

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?

DESCRIPTION

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

TEA TREE OIL ANTISEPTIC 
melaleuca alternifolia (tea tree) leaf oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70446-640
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	15 mL  in 15 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70446-640-02	1 in 1 CARTON	08/16/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70446-640-03	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2016
3	NDC: 70446-640-04	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/16/2016

Labeler - Integria Healthcare (Australia) Pty. Ltd. (741396386)

Establishment
Name	Address	ID/FEI	Business Operations
Integria Healthcare (Ballina) Pty Ltd		750660367	manufacture(70446-640)