Otc - Active Ingredient
Active Ingredient: melaleuca Alternifolia (Tea Tree) Leaf Oil 5%
Thursday Plantation
FDA Label NDC 66141-643
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 66141-643). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses: minor burns, sunburn, minor skin irritations, scratches, dry skin, reduces inflammation
Warnings
Warnings:
For external use only
Otc - When Using
When using this product - 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 - in case of deep puncture wounds or serious burns, consult a doctor.
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
Directions - apply to the affected areas as often as needed.
Description
Other Information - store below 86 degrees F.
Integria Healthcare Australia Pty Ltd
8 Clunies Ross Court, Eight Mile Plains
QLD 4113 Australia
www.thursdayplantation.com
USA: Integria Healthcare (Australia) Pty Ltd.
PO Box 4854, Eight Mile Plains
QLD 4113 Australia
USA Phone: 1-866-273-0377
Inactive Ingredient
Inactive Ingredients: Bentonite, Cetyl Alcohol, Glycerin, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Sodium Hydroxymethylglycinate, Sodium Stearoyl Lactylate, Water, Xantham Gum.
Package Label.Principal Display Panel
Thursday Plantation
Tea Tree Antiseptic Cream
Gently soothes and relieves
Tea Tree Antiseptic Cream Label (Teatree)
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