FDA.reportPublic FDA data

Seborrheic Dermatitis and Psoriasis Cream

Manufacturer
Ehy Holdings LLC
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:15

Label at a glance#

ProductSeborrheic Dermatitis and Psoriasis Cream
Active ingredientWORMWOOD
Label structure14 sections

Dosage and administration

Adult and children over 12 vears or old. Wash handsbefore and after applying the cream. Apply to affected area at the firstsign of blisters, sores, or tingling sensation. Rub in gently andthoroughly. Do not use more than 3 times daily. Children under 12years: ask a doctor

Storage and handling

Stor at room temperature and out of directsunlight.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

ARTEMISIA EXTRACT 【FHFI】3%

Purpose

OTC - PURPOSE SECTION

Seborrheic

Use

INDICATIONS & USAGE SECTION

Relieves and helps preventrecurrence of scalp: itching, flakingscaling, redness, and irritationassociated with psoriasis andseborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use morethan 3 times daily. Children under12 years: ask a doctor

OTC - WHEN USING SECTION

When using this productavoid contact with eyes.

OTC - STOP USE SECTION

condition worsens or does notimprove after regular use asdirected

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help orcontact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children over 12 vears or old. Wash handsbefore and after applying the cream. Apply to affected area at the firstsign of blisters, sores, or tingling sensation. Rub in gently andthoroughly. Do not use more than 3 times daily. Children under 12years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Stor at room temperature and out of directsunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Artemisia extractsSophora Flavescens, Cnidium Monnieri (L) Cuss., Kochiascoparia, Dictamni Cortex, Smilax Glabra Roxb, SolidagoDecurrens, Phellodendron amurense Ruprecht., GleditsiaSinensis

OTC - ASK DOCTOR SECTION

than 3 times daily. Children under12 years: ask a doctor

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81799-006-1

1

81799-006-1 181799-006-1 1

81799-006-1

2

81799-006-1 281799-006-1 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81799-006-012024-07-30C16284748780-11030e365-41cb-111a-e063-dadaa90a10e281799-006 Seborrheic Dermatitis and Psoriasis Cream
81799-006-012024-01-30C16284748780-11030e365-41cb-111a-e063-dadaa90a10e281799-006 Seborrheic Dermatitis and Psoriasis Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81799-006-01Seborrheic Dermatitis and Psoriasis Cream100 mL in 1 BOTTLECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81799-006SEBORRHEIC DERMATITIS AND PSORIASIS CREAM (ROYCEDERM SEBORRHEIC DERMATITIS AND PSORIASIS CREAM) CREAM [EHY HOLDINGS LLC]2Legacy NDC, 1 package rows20230113_f20d311b-610b-42a8-e053-2995a90ab341.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81799-00681799-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICTAMNUS DASYCARPUS ROOT6153LEN214IACT
WATER059QF0KO0RIACT
BORNEOLM89NIB437XIACT
WORMWOODF84709P2XVACTIB
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
BASSIA SCOPARIA POLLEN07A108ZKW5IACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT

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
f20d62d3-b2d5-6915-e053-2a95a90ad194f20d311b-610b-42a8-e053-2995a90ab3412023-01-12WarningsExact identifier
spl id: f20d62d3-b2d5-6915-e053-2a95a90ad194
spl set id: f20d311b-610b-42a8-e053-2995a90ab341

Reported adverse events (FAERS/openFDA)#

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