83887-004

Manufacturer
Changsha Beiliang E-commerce Co., Ltd
Effective date
2025-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:17

Label at a glance#

ProductPureskin Scalp Protection anti dandruff shampoo.
Active ingredientKETOCONAZOLE
Label structure14 sections

Dosage and administration

Wet hair thoroughly. Apply shampoo, gently lather and massage for 2 minutes, Rinse thoroughly. Use 2-3 times per week for up to 8 weeks or as directed by a doctor

Storage and handling

Store at 20°C to 25°C (68°F - 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ketoconazole 0.5%

Purpose

OTC - PURPOSE SECTION

dandruff

Use

INDICATIONS & USAGE SECTION

controls flaking, scaling and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or inflamed scalp.
if you are pregnant or breast feeding.
on children under 12 years old.

When Using

OTC - WHEN USING SECTION

avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.
Keep out of the reach of young children.

Stop Use

OTC - STOP USE SECTION

No improvement after 4 weeks of normal usage.

Ask Doctor

OTC - ASK DOCTOR SECTION

irritation or rash occurs.
condition worsens or does not improve in 2-4 weeks.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hair thoroughly.
Apply shampoo, gently lather and massage for 2 minutes, Rinse thoroughly.
Use 2-3 times per week for up to 8 weeks or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua
Glycerin
Sodium Cocoyl Isethionate
Propylene Glycol
Aloe Vera
Citric Acid
Rosemary
Tea Tree Oil
Witch Hazel
Chinese Mugwort Leaf
Licorice
Ethylhexylglycerin
Purslane
Sodium Chloride
Serine
Arginine
Coconut Oil
Peppermint

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
425918ketoconazole 0.5 % Medicated ShampooPSN1
425918ketoconazole 5 MG/ML Medicated ShampooSCD1
425918ketoconazole 0.5 % Medicated ShampooSY1

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83887-004-01Pureskin Scalp Protection anti dandruff shampoo.300 mL in 1 BOTTLESHAMPOO3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83887-004PURESKIN SCALP PROTECTION ANTI DANDRUFF SHAMPOO. (PURESKIN SCALP PROTECTION ANTI DANDRUFF SHAMPOO) SHAMPOO [CHANGSHA BEILIANG E-COMMERCE CO., LTD]11 package rows20250205_2d38d7f4-6c99-182d-e063-6294a90a7b33.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83887-00483887-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
2d38d7f4-6c9a-182d-e063-6294a90a7b332d38d7f4-6c99-182d-e063-6294a90a7b332025-02-03WarningsExact identifier
spl id: 2d38d7f4-6c9a-182d-e063-6294a90a7b33
spl set id: 2d38d7f4-6c99-182d-e063-6294a90a7b33

Reported adverse events (FAERS/openFDA)#

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