FDA.reportPublic FDA data

Anti-Fungal

Manufacturer
Shenzhen Mengyue Technology Co., Ltd.
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:24

Label at a glance#

ProductAnti-Fungal
Active ingredientKETOCONAZOLE, SALICYLIC ACID
Label structure12 sections

Indications and uses

Controls fungus that can cause dandruff Relieves and helps prevent recurrence of scalp: 1.irritation 2. itching 3.redness 4. flaking 5. scaling due to psoriasis and seborrheic dermatitis

Dosage and administration

adults and children 12 years and over - wet hair thoroughly - apply shampoo, generously lather, rinse thoroughly.Repeat - use every 3-4 days for up to 8 weeks or as directed by a doctor.Then use only as needed to control dandruff children under 12 years - ask a doctor

Storage and handling

- store at 20℃ to 25℃ (68°F-77°F) - see top panel for lot number and expiration date

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 1%

Salicylic Acid 2%

OTC - PURPOSE SECTION

Anti-Fungal shampoo

Psoriasis & seborheic dermatitis shampoo

Uses

INDICATIONS & USAGE SECTION

Controls fungus that can cause dandruff

Relieves and helps prevent recurrence of scalp:

1.irritation 2. itching 3.redness 4. flaking 5. scaling

due to psoriasis and seborrheic dermatitis

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

- on scalp that is broken or inflamed

- if you are allergic to ingredients in this product

When using this product

OTC - WHEN USING SECTION

- avoid contact with eyes

- if product gets into eyes,rinse thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

- rash appears

- condition worsens or does not improve in 2-4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a doctor before use.

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over

- wet hair thoroughly

- apply shampoo, generously lather, rinse thoroughly.Repeat

- use every 3-4 days for up to 8 weeks or as directed by a doctor.Then use only as needed to control dandruff

children under 12 years

- ask a doctor

Other information

STORAGE AND HANDLING SECTION

- store at 20℃ to 25℃ (68°F-77°F)

- see top panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis Leaf Juice, avena sativa (Oat) kernel extract, blue I citric acid, cocamide MEA, mentha piperita oilglycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, panthenol, polyquatemium-7, sodium benzoate, sodium chloride, Sodium Coco-Sulfate, sodium hydroxide,tetrasodium EDTA, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87255-009-0187255-009-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87255-009-01Anti-Fungal300 mL in 1 BOTTLESHAMPOO3001

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87255-00987255-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATZ6J799EAJKIACT
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT
COCAMIDE MEAC80684146DIACT
POLYQUATERNIUM-70L414VCS5YIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID2968PHW8QPIACT
DISPERSE BLUE 12429NAZ8WHIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM COCO-SULFATE3599J29ANHIACT
TETRASODIUM EDTAMP1J8420LUIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
KETOCONAZOLER9400W927IACTIB
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
PANTHENOLWV9CM0O67ZIACT
SALICYLIC ACIDO414PZ4LPZACTIB
ALOEV5VD430YW9IACT

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
Anti-FungalANTI-FUNGAL SHAMPOOShenzhen Mengyue Technology Co., Ltd.4ca9a661-fa39-ab7f-e063-6294a90aed142026-03-10WarningsExact identifier
ndc (package): 87255-009-01
ndc (product): 87255-009
ndc11 (package): 87255000901
spl id: 4ca9a538-cd16-bea2-e063-6394a90a2b6f
spl set id: 4ca9a661-fa39-ab7f-e063-6294a90aed14

Reported adverse events (FAERS/openFDA)#

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