SPL v1
SPL
SPL Set ID 3930ab37-9d6a-424e-9eac-a55283afc303
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melaleuca Alternifolia (tea Tree) Leaf Oil (6 [hp_X]) English Lavender Oil (4 [hp_X]) Oregano Leaf Oil (10 [hp_Q]) Undecylenic Acid Thyme Oil
Inactive Ingredients
Cocamidopropyl Betaine Glycerin Water Anhydrous Citric Acid Sodium Benzoate Potassium Sorbate Aloe Vera Leaf Matricaria Chamomilla Whole Xanthan Gum Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-10-30

Description

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment Oregano Oil   6X HPx                                                Antifungal treatment Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment Undecylenic Acid    10X HPx                                       Antifungal treatment

Purpose

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment Oregano Oil   6X HPx                                                Antifungal treatment Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment Undecylenic Acid    10X HPx                                       Antifungal treatment


Medication Information

Purpose

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment Oregano Oil   6X HPx                                                Antifungal treatment Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment Undecylenic Acid    10X HPx                                       Antifungal treatment

Description

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment Oregano Oil   6X HPx                                                Antifungal treatment Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment Undecylenic Acid    10X HPx                                       Antifungal treatment

Uses

For the treatment of most



● jock itch (tinea cruris)

● ringworm (tinea corporis)

● athlete's foot (tinea pedis)

● tinea versicolor

For relief of:

● itching

● scaling

● cracking

● burning

● irritation

Warnings

For external use only

Ask a doctor before useon children under 2 years of age.



When using this  product, avoid contact with the eyes. If contact occurs rinse thoroughly with water.



Stop use and ask a doctor if

● irritation occurs

● there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot, and tinea versicolor).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direactions

Read all package directions and warnings before use.

● Use only as directed.

● Clean the affected area with Anti-Fungal Wash and warm water, rinse and dry

thoroughly.

● For best results, leave on for 1-2 minutes before rinsing and drying.

● Use twice daily (morning and night), or as directed by a doctor.

● This product is not effective on scalp or nails.

● For jock itch, use daily for 2 weeks.

● For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition

persists longer, consult a doctor.

● For athlete's foot: pay special attention to spaces between the toes; wear well-fitting,

ventilated shoes, and change shoes and socks at least once daily.

● Intended for use by normally healthy adults only.

● Persons under 18 years of age or those with highly sensitive or allergic skin should

use only as directed by a doctor.

● Supervise children in the use of this product.

Product Label

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Sodium Chloride, Glycerin, Citric Acid, Sodium Benzoate, Potassium Sorbate, Aloe Vera Extract (Aloe

barbadensis), Chamomile Extract (Matricaria chamomilla), Xanthan Gum.

Active Ingredient                                            Purpose

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment

Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment

Oregano Oil   6X HPx                                                Antifungal treatment

Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment

Undecylenic Acid    10X HPx                                       Antifungal treatment


Structured Label Content

Uses

For the treatment of most



● jock itch (tinea cruris)

● ringworm (tinea corporis)

● athlete's foot (tinea pedis)

● tinea versicolor

For relief of:

● itching

● scaling

● cracking

● burning

● irritation

Warnings

For external use only

Ask a doctor before useon children under 2 years of age.



When using this  product, avoid contact with the eyes. If contact occurs rinse thoroughly with water.



Stop use and ask a doctor if

● irritation occurs

● there is no improvement within 2 weeks (4 weeks for ringworm, athlete's foot, and tinea versicolor).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direactions

Read all package directions and warnings before use.

● Use only as directed.

● Clean the affected area with Anti-Fungal Wash and warm water, rinse and dry

thoroughly.

● For best results, leave on for 1-2 minutes before rinsing and drying.

● Use twice daily (morning and night), or as directed by a doctor.

● This product is not effective on scalp or nails.

● For jock itch, use daily for 2 weeks.

● For ringworm, tinea versicolor and athlete's foot, use daily for 4 weeks. If condition

persists longer, consult a doctor.

● For athlete's foot: pay special attention to spaces between the toes; wear well-fitting,

ventilated shoes, and change shoes and socks at least once daily.

● Intended for use by normally healthy adults only.

● Persons under 18 years of age or those with highly sensitive or allergic skin should

use only as directed by a doctor.

● Supervise children in the use of this product.

Product Label (Product label)

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Sodium Chloride, Glycerin, Citric Acid, Sodium Benzoate, Potassium Sorbate, Aloe Vera Extract (Aloe

barbadensis), Chamomile Extract (Matricaria chamomilla), Xanthan Gum.

Active Ingredient                                            Purpose (Active ingredient                                            Purpose)

Tea Tree Oil (Melaleuca alternifolia) 6X HPx                  Antifungal treatment

Thyme Oil (Thymus vulgaris) – 6X HPx                        Antifungal treatment

Oregano Oil   6X HPx                                                Antifungal treatment

Lavender Oil (Lavandula angustifolia)  4X HPx            Antifungal treatment

Undecylenic Acid    10X HPx                                       Antifungal treatment


Advanced Ingredient Data


Raw Label Data

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