49f88ab5-2409-1b4c-e063-6394a90a5d69

SPL v1
SPL
SPL Set ID 49f88ab5-2409-1b4c-e063-6394a90a5d69
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 (1 g)
Inactive Ingredients
dictamnus dasycarpus root bark bassia scoparia fruit butyrospermum parkii (shea) butter sophora flavescens root propylene glycol 1,2-distearate cocamidopropyl betaine sucrose cnidium monnieri fruit oil olea europaea (olive) fruit oil sodium lauroyl sarcosinate stearic acid sorbitol elaeis guineensis (palm) oil water glycerin myristic acid lauric acid phellodendron chinensis bark prunus amygdalus dulcis (sweet almond) oil sodium laureth sulfate pseudolarix amabilis bark

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2025-02-01

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


Medication Information

Warnings



For external use only

Uses



Helps relieve dryness, itching, redness,

and discomfort caused by eczema-prone skin.

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.

Other Information



Store at room temperature.

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.

Description

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

Lable

Stop Use



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

adverse reactions occur

Ask A Doctor



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Active Ingredients

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

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

Warnings



For external use only

Uses



Helps relieve dryness, itching, redness,

and discomfort caused by eczema-prone skin.

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.

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.

Other Information (Other information)



Store at room temperature.

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.

Lable

Stop Use (Stop use)



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

adverse reactions occur

Ask A Doctor (Ask a doctor)



Stop use and ask

a doctor if rash or irritation appears or if any

adverse reactions occur

Active Ingredients (Active ingredients)

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

When Using This Product (When using this product)



avoid contact with the eyes

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

All Sections (JSON)