TEA TREE ANTISEPTIC CREAM (melaleuca alternifolia- tea tree leaf oil cream

Tea Tree Antiseptic Cream by

Drug Labeling and Warnings

Tea Tree Antiseptic Cream by is a Otc medication manufactured, distributed, or labeled by Integria Healthcare (Australia) Pty. Ltd., Tismor Health & Wellness Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

PURPOSE

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 or 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 persists or gets worse.

Keep out of reach of children.  If swallowed, 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 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

INACTIVE INGREDIENT

Bentonite, Cetyl Alcohol, Citric Acid, Glycerin, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Sodium Hydroxymethylglycinate, Sodium Stearoyl Lactylate, Water, Xanthan Gum.

DESCRIPTION

MADE IN AUSTRALIA

Manufactured for: Integria Healthcare (Australia) Pty Ltd.,

Building 5, Freeway Office Park, 2728 Logan Road,

Eight Mile Plains, QLD 4113 Australia

us.thursdayplantation.com

Questions or Comments?

1-877-428-2567

Best Before and Batch # stamped in tube seal

PRINCIPAL DISPLAY PANEL

NDC: 70446-643-50

Thursday

Plantation

Australia's Original

TEA TREE

ANTISEPTIC

CREAM

Gently soothes and relieves minor skin irritations

Net wt.

3.5 oz/100g

INGREDIENTS AND APPEARANCE

TEA TREE ANTISEPTIC CREAM 
melaleuca alternifolia (tea tree) leaf oil cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70446-643
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	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MACADAMIA OIL (UNII: 515610SU8C)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70446-643-50	100 g in 1 TUBE; 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		06/18/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Tismor Health & Wellness Pty Ltd		757701409	manufacture(70446-643)