Otc - Active Ingredient
Melaleuca Alternifolia (Tea Tree) Leaf Oil 5% ...... Antiseptic
Thursday Plantation
FDA Label NDC 66141-644
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 66141-644). 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: protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection.
Warnings
For external use only.
In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Otc - Stop Use
Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.
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: clean the affected area. apply small amount two or three times a day. may be covered with a sterile bandage.
Storage And Handling
store below 86 degrees F.
Package Label.Principal Display Panel
Thursday Plantation
Australia's Original
Tea Tree Antiseptic
With Vitamin E
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 Ointment Label (Teatreeointment50g)
Inactive Ingredient
Inactive Ingredients: Cetearyl Alcohol, Mineral Oil, Paraffin, Sodium Lauryl Sulfate, Tocopheryl Acetate (vitamin E).
* Please review the disclaimer below.
