TEA TREE ANTISEPTIC - melaleuca alternifolia oil 
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 100%

Antiseptic

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

For external use only

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

Keep out of reach of children


store below 86 degrees F

Tea Tree Oil Antiseptic

100% Pure

Minimum 36% Terpinen-4-ol

Tea Tree Oil 15 mL Carton

Tea Tree Oil 15 mL Label



None.

TEA TREE ANTISEPTIC 
melaleuca alternifolia oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL15 mL  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51257-640-0110 mL in 1 BOTTLE
2NDC:51257-640-0215 mL in 1 BOTTLE
3NDC:51257-640-0325 mL in 1 BOTTLE
4NDC:51257-640-0450 mL in 1 BOTTLE
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: 2bbb3e50-1128-47c2-bd24-1ef0097f04d3
Set id: 31952c39-8b43-4e93-b2e8-9388da8bdaf8
Version: 2
Effective Time: 20110317
 
Integria Healthcare US Inc.