TEA TREE ANTISEPTIC- melaleuca alternifolia 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., Integria Healthcare (Ballina) . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

PURPOSE

Antiseptic

INDICATIONS & USAGE

protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection

WARNINGS

For external use only

ASK DOCTOR

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

STOP USE

Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.

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

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

STORAGE AND HANDLING

store below 86 degrees F

INACTIVE INGREDIENT

Beeswax, Canola Oil, Copernicia Cerifera (Carnauba) Wax, Macadamia Integrifolia Seed Oil, Tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEA TREE ANTISEPTIC 
melaleuca alternifolia ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51257-644
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	2.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CANOLA OIL (UNII: 331KBJ17RK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MACADAMIA OIL (UNII: 515610SU8C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51257-644-01	50 g in 1 JAR

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