SPL v2
SPL
SPL Set ID 3ca2ffbc-1cdc-0ebd-e063-6394a90af47a
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tea Tree Oil (3 g)
Inactive Ingredients
Sorbitol Mentha Arvensis Whole Cocos Nucifera (coconut) Oil Elaeis Guineensis (palm) Oil Water Calendula Officinalis Whole Chrysanthellum Indicum Whole Wolfiporia Cocos Whole Hydrogenated Olive Oil Butyrospermum Parkii (shea) Butter Glycerin Beeswax Sucrose Myristic Acid Sodium Dodecylbenzenesulfonate Lauric Acid Sodium Stearate Curcuma Longa (turmeric) Root Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-02-01

Description

Tea tree oil 3% ------------------------------- Anti-fungal

Dosage and Administration

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin for two minutes, then rinse completely and pat dry gently.


Medication Information

Indications and Usage

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin fortwo minutes, then rinse completely and pat dry gently.

Dosage and Administration



First, wet your skin. Then lather the soap in

your hands, and apply the lather to your face

or body in a circular motion. Leave on skin for

two minutes, then rinse completely and pat dry

gently.

Description

Tea tree oil 3% ------------------------------- Anti-fungal

Uses



Helps relieve dryness, itching, redness,

and discomfort caused by eczema-prone skin.

Lable

Stop Use



Stop use and ask a doctor if rash or irritation appears or if any

adverse reactions occur

Warnings



For external use only

Ask A Doctor



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Other Information



Store at room temperature.

Active Ingredients

Tea tree oil 3% ------------------------------- Anti-fungal

Inactive Ingredients

Water, Glycerin, Sorbitol, Sucrose, Elaeisguineensis (palm) oil, Cocos nucifera (coconutoil, Butyrospermum parkii (shea butter),

Hydrogenated olive oil, Curcuma longa(turmeric) root extract, Calendula officinalisextract, Mentha arvensis extract, Lauric acid,Myristic acid, Salicylic acid, Sulfur, Sodiumstearate, Sodium dodecyl sulfate, Benzoylperoxide, Propylene glycol.

When Using This Product



avoid contact with the eyes

Keep Out of Reach of Children

If swallowed, call a poison control center or seek medical attention immediately.


Structured Label Content

Uses



Helps relieve dryness, itching, redness,

and discomfort caused by eczema-prone skin.

Lable

Indications and Usage (34067-9)

First, wet your skin. Then lather the soap in your hands, and apply the lather to your face or body in a circular motion. Leave on skin fortwo minutes, then rinse completely and pat dry gently.

Stop Use (Stop use)



Stop use and ask a doctor if rash or irritation appears or if any

adverse reactions occur

Warnings



For external use only

Ask A Doctor (Ask a doctor)



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Other Information (Other information)



Store at room temperature.

Active Ingredients (Active ingredients)

Tea tree oil 3% ------------------------------- Anti-fungal

Inactive Ingredients

Water, Glycerin, Sorbitol, Sucrose, Elaeisguineensis (palm) oil, Cocos nucifera (coconutoil, Butyrospermum parkii (shea butter),

Hydrogenated olive oil, Curcuma longa(turmeric) root extract, Calendula officinalisextract, Mentha arvensis extract, Lauric acid,Myristic acid, Salicylic acid, Sulfur, Sodiumstearate, Sodium dodecyl sulfate, Benzoylperoxide, Propylene glycol.

When Using This Product (When using this product)



avoid contact with the eyes

Dosage and Administration (Dosage and administration)



First, wet your skin. Then lather the soap in

your hands, and apply the lather to your face

or body in a circular motion. Leave on skin for

two minutes, then rinse completely and pat dry

gently.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, call a poison control center or seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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