TEA TREE ANTISEPTIC- tea tree oil ointment

Tea Tree Antiseptic by

Drug Labeling and Warnings

Tea Tree Antiseptic by is a Otc medication manufactured, distributed, or labeled by Integria Healthcare (US) Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Purpose

First Aid Antiseptic

Uses

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

Warnings

For external use only

Do not Use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor.

Ask a 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 worsens.

Keep out of reach of children.

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

Directions

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

Other information

• store below 86 F.
  

Inactive ingredients

Paraffin white soft, Mineral oil, Cetostearyl alcohol, dl-alpha tocopheryl acetate

DESCRIPTION

DISTRIBUTED BY: Integria Healthcare (US) Inc., Paramount CA 90723-3426.

USA Health Food: Natural Organics Inc, 548 Broadhollow Road Melville NY 11747

MADE IN AUSTRALIA

Principal Display Panel

NDC: 51257-642-02

Thursday Plantation

Australia's Original

TEA TREE ANTISEPTIC OINTMENT

First aid to help protect

against infection in minor

cuts, scrapes and burns

Net Wt 1.76 oz (50 g)

INGREDIENTS AND APPEARANCE

TEA TREE ANTISEPTIC  
tea tree oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51257-642
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	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51257-642-02	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/27/2013

Labeler - Integria Healthcare (US) Inc (962379454)