FDA.reportPublic FDA data

83818-015

Manufacturer
Shenzhen Xinxin Yunhai Technology Co., Ltd.
Effective date
2025-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:43

Label at a glance#

ProductPHARMBANNER Anti-Fungal Shampoo.
Active ingredientHEXAMIDINE DIISETHIONATE
Label structure14 sections

Dosage and administration

▪ 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.

Storage and handling

▪ Store in a cool, dry place away from direct sunlight ▪ Do not use if seal is broken or missing

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

HEXAMIDINE DIISETHIONATE 0.1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

▪ Helps relieve symptoms of fungal and inflammatory skin conditions, including:
– Folliculitis
– Dandruff
– Seborrheic dermatitis
– Tinea versicolor
– Jock itch
▪ Reduces itching, flaking, redness, and irritation

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

▪ On broken or severely damaged skin without consulting a doctor

When Using

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

▪ Irritation or rash occurs and lasts

Ask Doctor

OTC - ASK DOCTOR SECTION

▪ A known allergy to any of the listed ingredients
▪ Severe skin conditions not diagnosed by a doctor

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

▪ 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.

Other information

STORAGE AND HANDLING SECTION

▪ Store in a cool, dry place away from direct sunlight
▪ Do not use if seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

Questions

OTC - QUESTIONS SECTION

Email us at: cs@pharmbanners.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2717261hexamidine diisethionate 0.1 % Medicated ShampooPSN1
2717261hexamidine diisethionate 1 MG/ML Medicated ShampooSCD1
2717261hexamidine diisethionate 0.1 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83818-015-01PHARMBANNER Anti-Fungal Shampoo.250 mL in 1 BOTTLESHAMPOO2501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83818-01583818-015-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURETH SULFATEBPV390UAP0IACT
UREA8W8T17847WIACT
C12-15 PARETH-3459EF9MP3YIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
RHEUM OFFICINALE ROOTA47JP5ZG9MIACT
POLYGONUM ARENASTRUM WHOLEM7IQ4O4186IACT
HOUTTUYNIA CORDATA TOP3E4MG0DM0MIACT
FOENICULUM VULGARE ROOT0Q23FEN5N3IACT
TARAXACUM MONGOLICUM4E8QL88U6HIACT
CITRIC ACID2968PHW8QPIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
NYMPHAEA ALBA FLOWER40KQ7Q535OIACT
EDETATE DISODIUM7FLD91C86KIACT
SALICYLIC ACIDO414PZ4LPZIACT
HEXAMIDINE DIISETHIONATE023XA5Z50LACTIB
GLYCOL STEARATE0324G66D0EIACT
PANAX GINSENG ROOTCUQ3A77YXIIACT
COPTIS CHINENSIS WHOLE67444F3ESDIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL 1,3-DI(5-HYDROXYDECANOATE)EFZ65410Y6IACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE1R81RPY10GIACT
MENTHOLL7T10EIP3AIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
ndc (package): 83818-015-01
ndc (product): 83818-015
ndc11 (package): 83818001501
spl id: 383926b7-997c-af1e-e063-6394a90a506d
spl set id: 383926b7-997b-af1e-e063-6394a90a506d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.