Oz Tree
FDA Label NDC 58982-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oz Soap Tree for the product Oz Tree (NDC 58982-010). 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 active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label. principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active ingredient: Allantoin 0.5%

Inactive Ingredient

Inactive ingredients: Coconut Oil, Palm Oil, Olive Extra Virgin Oil, Castor Oil, Shea Butter Oil, Canola Oil, Seaweed Powder, Orange e.o, Tea Tree e.o

Purpose

Purpose: Skin Cleansing, Skin Protectant

Warnings

Warnings:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
- In case of having problem such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

Keep Out Of Reach Of Children

Keep out of reach of children:
Keep out of reach of babies and children.

Indications And Usage

Indication and usage:
Don't keep it in the place where the temperature is extremely hot or tow and exposed to the direct sunlight.

Dosage And Administration

Dosage and administration:
Use hands to lather facial soap over makeup free face and throat.
Rinse with tepid water. Pat dry. Use Twice daily.

* Please review the disclaimer below.