TEA TREE ANTISEPTIC- melaleuca alternifolia oil

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., Integria Healthcare (Ballina) . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%

PURPOSE

Antiseptic

INDICATIONS & USAGE

treats minor cuts, minor burns, scrapes, abrasions, insect bites and stings.

WARNINGS

For external use only

• avoid contact with eyes, mouth, ears and other sensitive areas of the body
• if contact occurs, rinse thoroughly with water
  

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

• apply to the affected area
• use sparingly by drop
• children under 12 years of age: consult a doctor
  

STORAGE AND HANDLING

store below 86 degrees F

PRINCIPAL DISPLAY PANEL

Tea Tree Oil Antiseptic

100% Pure

Minimum 36% Terpinen-4-ol

INACTIVE INGREDIENT

None.

INGREDIENTS AND APPEARANCE

TEA TREE ANTISEPTIC 
melaleuca alternifolia oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51257-640
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: 51257-640-01	10 mL in 1 BOTTLE
2	NDC: 51257-640-02	15 mL in 1 BOTTLE
3	NDC: 51257-640-03	25 mL in 1 BOTTLE
4	NDC: 51257-640-04	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2011

Labeler - Integria Healthcare US Inc. (962379454)

Registrant - Integria Healthcare US Inc. (962379454)

Establishment
Name	Address	ID/FEI	Business Operations
Integria Healthcare (Ballina)		750660367	manufacture