Otc - Active Ingredient
Melaleuca Alternifolia (Tea Tree) Leaf Oil 100% ...... Antiseptic
Thursday Plantation
FDA Label NDC 66141-641
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 Ballina for the product Thursday Plantation (NDC 66141-641). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, otc - purpose, 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
Indications & Usage
Uses: treats minor cuts, minor burns, scrapes, abrasions, insect bites and stings.
Warnings
For external use only.
Avoid contact with eyes, mouth, ears or 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.
Otc - Purpose
Antiseptic
Dosage & Administration
Directions: 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
Thursday Plantation
Australia's Original
Tea Tree Antiseptic
100% Pure
Minimum 36% Terpinen-4-ol
Distributed By:
Integria Healthcare Australia
Pty Ltd 8 Clunies Ross Court
Eight Mile Plains, QLD 4113
Australia
www.thursdayplantation.com
USA Phone: 1-866-273-0377
Made in Australia
Tea Tree Antiseptic Oil 50 mL (Teatreeoil50ml)
* Please review the disclaimer below.
