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Tea Tree Antiseptic by Integria Healthcare US Inc.

Dosage form: ointment
Ingredients: TEA TREE OIL 2.5g in 50g
Labeler: Integria Healthcare US Inc.
NDC Code: 51257-644

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 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.

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

store below 86 degrees F

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

TEA TREE ANTISEPTIC 
melaleuca alternifolia ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51257-644
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEA TREE OIL (TEA TREE OIL) TEA TREE OIL2.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
CANOLA OIL 
CARNAUBA WAX 
MACADAMIA OIL 
Packaging
#Item CodePackage Description
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/FEIOperations
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.

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