83818-015

83818-015
SPL v1
SPL
SPL Set ID 383926b7-997b-af1e-e063-6394a90a506d
Route
TOPICAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hexamidine (0.1 g)
Inactive Ingredients
Sodium Laureth Sulfate Urea C12-15 Pareth-3 Iodopropynyl Butylcarbamate Piroctone Olamine Rheum Officinale Root Polygonum Arenastrum Whole Houttuynia Cordata Top Foeniculum Vulgare Root Taraxacum Mongolicum Citric Acid Melaleuca Alternifolia (tea Tree) Leaf Oil Sodium Lauroamphoacetate Cocamidopropyl Betaine Sodium Chloride Nymphaea Alba Flower Edetate Disodium Salicylic Acid Glycol Stearate Panax Ginseng Root Coptis Chinensis Whole Dimethicone Glyceryl 1,3-di(5-hydroxydecanoate) Water Cetostearyl Alcohol Glycol Distearate Dihydrogenated Tallow Phthalic Acid Amide Menthol Guar Hydroxypropyltrimonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-23

Description

HEXAMIDINE DIISETHIONATE 0.1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

HEXAMIDINE DIISETHIONATE 0.1%

Use

▪ Helps relieve symptoms of fungal and inflammatory skin conditions, including:

– Folliculitis

– Dandruff

– Seborrheic dermatitis

– Tinea versicolor

– Jock itch

▪ Reduces itching, flaking, redness, and irritation

Stop Use

▪ Irritation or rash occurs and lasts

Warnings

For external use only

Questions

Email us at: [email protected]

Ask Doctor

▪ A known allergy to any of the listed ingredients

▪ Severe skin conditions not diagnosed by a doctor

Directions

▪ Apply a small amount to the affected area and lather gently.

▪ Leave on for 2–5 minutes before rinsing.

▪ Use 3 to 5 times per week or as directed by a doctor.

▪ For best results, use consistently.

Do Not Use

▪ On broken or severely damaged skin without consulting a doctor

When Using

▪ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

HEXAMIDINE DIISETHIONATE 0.1%

Other Information

▪ Store in a cool, dry place away from direct sunlight

▪ Do not use if seal is broken or missing

Inactive Ingredients

Aqua (Water), Sodium Laureth Sulfate, Urea, Cetearyl Alcohol, Dimethicone, Cocamidopropyl Betaine, C12-15 Pareth-3, Iodopropynyl Butylcarbamate, Glycol Distearate, Glycol Stearate, Sodium Lauroamphoacetate, Dihydrogenated Tallow Phthalic Acid Amide, Menthol, Piroctone Olamine, Glyceryl, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Nymphaea Alba Flower Extract, Coptis Chinensis Extract, Rheum Officinale Extract, Polygonum Multiflorum Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgare Extract, Taraxacum Mongolicum Extract, Panax Ginseng Root Extract, Citric Acid, Disodium EDTA, Salicylic Acid, Melaleuca Alternifolia (Tea Tree) Oil.

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

▪ Helps relieve symptoms of fungal and inflammatory skin conditions, including:

– Folliculitis

– Dandruff

– Seborrheic dermatitis

– Tinea versicolor

– Jock itch

▪ Reduces itching, flaking, redness, and irritation

Purpose

Antifungal

Stop Use

▪ Irritation or rash occurs and lasts

Warnings

For external use only

Questions

Email us at: [email protected]

Ask Doctor

▪ A known allergy to any of the listed ingredients

▪ Severe skin conditions not diagnosed by a doctor

Directions

▪ Apply a small amount to the affected area and lather gently.

▪ Leave on for 2–5 minutes before rinsing.

▪ Use 3 to 5 times per week or as directed by a doctor.

▪ For best results, use consistently.

Do Not Use (Do not use)

▪ On broken or severely damaged skin without consulting a doctor

When Using

▪ Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

HEXAMIDINE DIISETHIONATE 0.1%

Other Information (Other information)

▪ Store in a cool, dry place away from direct sunlight

▪ Do not use if seal is broken or missing

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Sodium Laureth Sulfate, Urea, Cetearyl Alcohol, Dimethicone, Cocamidopropyl Betaine, C12-15 Pareth-3, Iodopropynyl Butylcarbamate, Glycol Distearate, Glycol Stearate, Sodium Lauroamphoacetate, Dihydrogenated Tallow Phthalic Acid Amide, Menthol, Piroctone Olamine, Glyceryl, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Nymphaea Alba Flower Extract, Coptis Chinensis Extract, Rheum Officinale Extract, Polygonum Multiflorum Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgare Extract, Taraxacum Mongolicum Extract, Panax Ginseng Root Extract, Citric Acid, Disodium EDTA, Salicylic Acid, Melaleuca Alternifolia (Tea Tree) Oil.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.


Advanced Ingredient Data


Raw Label Data

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