Otc - Active Ingredient
Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%
Tea Tree Antiseptic
FDA Label NDC 51257-640
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Integria Healthcare Us Inc. for the product Tea Tree Antiseptic (NDC 51257-640). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Tea Tree Oil 15 mL Carton (15mlcarton)
Tea Tree Oil 15 mL Label (15mllabel)
Inactive Ingredient
None.
* Please review the disclaimer below.
