FDA Label for Tea Tree Antiseptic

View Indications, Usage & Precautions

Tea Tree Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Integria Healthcare Us Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%


Otc - Purpose



Antiseptic


Indications & Usage



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


Warnings



For external use only

  • avoid contact with eyes, mouth, ears and other sensitive areas of the body
  • if contact occurs, rinse thoroughly with water

Otc - Stop Use



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


Otc - 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



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

Storage And Handling



store below 86 degrees F


Package Label.Principal Display Panel



Tea Tree Oil Antiseptic

100% Pure

Minimum 36% Terpinen-4-ol






Inactive Ingredient



None.


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