FDA.reportPublic FDA data

83887-005

Manufacturer
Changsha Beiliang E-commerce Co., Ltd
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:41

Label at a glance#

ProductDERPHEA Advanced Scalp Shampoo.
Active ingredientSOPHORA FLAVESCENS ROOT, KETOCONAZOLE
Label structure14 sections

Dosage and administration

1 Gently massage scalp shampoo into your wet hair. 2 Leave shampoo for 5-7 minutes in the hair. 3 Gently massage into a lather and rinses cleanly away. 4 For best results, Repeat step 3.

Storage and handling

Store at room temperature, away from directsunlight.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sophora Flvescens 2%
Stemona tuberosa 1%

Purpose

OTC - PURPOSE SECTION

Seborrheic dermatitis,PsoriasisAnti-fungal, Anti itchy

Use

INDICATIONS & USAGE SECTION

Temporarily relieves and helps prevent the recurrence of scalp itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.
Allergy Alert: Consult a doctor before use if you are allergic to any ingredients in this product.

Do not use

OTC - DO NOT USE SECTION

On damaged or inflamed scalp.
If you are pregnant or breastfeeding.
In children under 12 years old.

When Using

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

Condition worsens or does not improve after regular use as directed.

Ask Doctor

OTC - ASK DOCTOR SECTION

Condition worsens after regular use as directed.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

1 Gently massage scalp shampoo into your wet hair.
2 Leave shampoo for 5-7 minutes in the hair.
3 Gently massage into a lather and rinses cleanly away.
4 For best results, Repeat step 3.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature, away from directsunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Latintite
gleditsia Inenesislinn
typhon Img i gateueng
Rhizoma Smi Lacis Glabrae
Dryobalanops spp
Stemona tuberosa
Menthacanadaensis L

Questions

OTC - QUESTIONS SECTION

info@derphea.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
83887-005-01DERPHEA Advanced Scalp Shampoo.240 mL in 1 BOTTLESHAMPOO2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83887-005DERPHEA ADVANCED SCALP SHAMPOO. (ADVANCED SCALP SHAMPOO) SHAMPOO [CHANGSHA BEILIANG E-COMMERCE CO., LTD]11 package rows20250223_2e89c938-e69f-1323-e063-6294a90aebdb.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83887-00583887-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KACTIB
STEMONA TUBEROSA WHOLE9373ZOT316IACT
KETOCONAZOLER9400W927IACTIB
SMILAX GLABRA TUBERPES3YXA3LRIACT
DRYOBALANOPS AROMATICA WHOLE34303GFW6AIACT
GLEDITSIA TRIACANTHOS WHOLED8MUI5CX2ZIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
MENTHA CANADENSIS WHOLEJ1BO4MHT2LIACT

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
2e89c938-e6a0-1323-e063-6294a90aebdb2e89c938-e69f-1323-e063-6294a90aebdb2025-02-19WarningsExact identifier
spl id: 2e89c938-e6a0-1323-e063-6294a90aebdb
spl set id: 2e89c938-e69f-1323-e063-6294a90aebdb

Reported adverse events (FAERS/openFDA)#

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