TEA TREE ANTISEPTIC - melaleuca alternifolia ointment 
Integria Healthcare US Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

Antiseptic

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

For external use only

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

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


Keep out of reach of children, if swallowed get medical help or contact a Poison Control Center right away.

store below 86 degrees F

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

Tea Tree Antiseptic Ointment Label

TEA TREE ANTISEPTIC 
melaleuca alternifolia ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-644
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL2.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CANOLA OIL (UNII: 331KBJ17RK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MACADAMIA OIL (UNII: 515610SU8C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51257-644-0150 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2011
Labeler - Integria Healthcare US Inc. (962379454)
Registrant - Integria Healthcare US Inc. (962379454)
Establishment
NameAddressID/FEIBusiness Operations
Integria Healthcare (Ballina) 750660367manufacture

Revised: 3/2011
Document Id: 58bedeaa-78d7-4baa-9810-ea7be458dd3c
Set id: 9534eb1d-89a7-4922-a121-742aa5418416
Version: 1
Effective Time: 20110317
 
Integria Healthcare US Inc.