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Tea Tree Antiseptic by Integria Healthcare US Inc.

Dosage form: oil
Ingredients: TEA TREE OIL 15mL in 15mL
Labeler: Integria Healthcare US Inc.
NDC Code: 51257-640

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.

Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%


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

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

Keep out of reach of children

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

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

store below 86 degrees F

Tea Tree Oil Antiseptic

100% Pure

Minimum 36% Terpinen-4-ol


melaleuca alternifolia oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-640
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
#Item CodePackage Description
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)
Integria Healthcare (Ballina) 750660367manufacture

Revised: 03/2011
Integria Healthcare US Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.