FDA.reportPublic FDA data

DERMOSCRIBE (as PLD) - SEBORRHEIC DERMATITIS CREAM (69683-202)

Manufacturer
DERMOSCRIBE PTY LTD
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:39:26

Label at a glance#

ProductDERMOSCRIBE SEBORRHEIC DERMATITIS
Active ingredientSULFUR, SALICYLIC ACID, HYDROCORTISONE
Label structure9 sections

Dosage and administration

Apply to affected area once or twice daily

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3%, Salicylic Acid 3%, Hydrocortisone 1%

PURPOSE

OTC - PURPOSE SECTION

SEBORRHEIC DERMATITIS CREAM

USE

INDICATIONS & USAGE SECTION

For relief of itching, scaling, redness, flaking and irritation associated with seborrheic dermatitis

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

Ask a doctor before use if condition covers a large area of the body

When using this product avoid contact with eyes. If contact occurs, rinse eye thoroughly with water

Stop use and consult a doctor if condition worsens or does not improve after regular use as directed

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, seek medical advice or contact a Poison Control Center immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to affected area once or twice daily

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Oil, Carbomer, Ceteryl Alcohol, Coconut Oil, Extract of Aloe Vera, Glycerine, Glycol Sterate, Grapefruit Seed Extract, Polysorbate 20, Purified Water, Sodium Hydroxide, Sorbitol

RECENT MAJOR CHANGES SECTION

Update drug facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Seb Derm Tube Back View_Mar 2025Seb Derm Tube Back View_Mar 2025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1738574hydrocortisone 1 % / salicylic acid 3 % / sulfur 3 % Topical CreamPSN9
1738574hydrocortisone 10 MG/ML / salicylic acid 30 MG/ML / sulfur 30 MG/ML Topical CreamSCD9
1738574hydrocortisone 1 % / salicylic acid 3 % / sulfur 3 % Topical CreamSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69683-202-11DERMOSCRIBE SEBORRHEIC DERMATITIS60 g in 1 BOTTLECREAM609

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69683-20269683-202-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
GRAPEFRUITO82C39RR8CIACT
ALOE VERA LEAF OILJQ7YW886UQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCOL STEARATE SE6YLY96TQL6IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-10-14full-release2026-06-01 00:35:32

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
DERMOSCRIBE SEBORRHEIC DERMATITISSULFUR, SALICYLIC ACID, HYDROCORTISONEDERMOSCRIBE PTY LTD2b6bf90b-5d42-4c08-afee-56e13122285e2025-10-17WarningsExact identifier
ndc (package): 69683-202-11
ndc (product): 69683-202
ndc11 (package): 69683020211
spl id: 4161aee0-5f36-1739-e063-6294a90a5bdf
spl set id: 2b6bf90b-5d42-4c08-afee-56e13122285e

Reported adverse events (FAERS/openFDA)#

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