FDA.reportPublic FDA data

Dermarest Eczema Medicated Lotion

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:33:34

Label at a glance#

ProductDermarest Eczema Medicated
Active ingredientHYDROCORTISONE
Label structure10 sections

Indications and uses

temporary relief of itching associated with minor skin irritations inflammation rashes due to eczema Other uses of this product should be only under the advice and supervision of a doctor.

Dosage and administration

adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily children under 2 years of age do not use, consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dermarest™ Eczema
Medicated Lotion

Keep carton for future reference.

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

temporary relief of itching associated with

  • minor skin irritations
  • inflammation
  • rashes due to eczema

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

for the treatment of diaper rash

When using this product

OTC - WHEN USING SECTION

do not get into the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily
children under 2 years of agedo not use, consult a doctor

Other Information

OTHER SAFETY INFORMATION

  • shake well
  • store at room temperature 15° - 25°C (59°- 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermarest®

Eczema
Medicated
Lotion

Hydrocortisone 1%
Anti-Itch Lotion
4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL Dermarest® Eczema Medicated Lotion Hydrocortisone 1% Anti-Itch Lotion 4 FL OZ (118 mL)PRINCIPAL DISPLAY PANEL Dermarest® Eczema Medicated Lotion Hydrocortisone 1% Anti-Itch Lotion 4 FL OZ (118 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103403hydrocortisone 1 % Topical LotionPSN7
103403hydrocortisone 10 MG/ML Topical LotionSCD7
103403hydrocortisone 1 % Topical LotionSY7

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
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
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product 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
63736-339-24DermarestEczema Medicated24 in 1 CASELOTION247
63736-339-24DermarestEczema Medicated1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-339DERMAREST ECZEMA MEDICATED (HYDROCORTISONE) LOTION [INSIGHT PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20241105_0292ab62-5088-45fa-a056-70c2fcc19ef7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ3
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN3
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R3
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K3
GlycerinINACTIVE INGREDIENTPDC6A3C0OX3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE43
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B03
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T3
PanthenolINACTIVE INGREDIENTWV9CM0O67Z3
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V33
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH3
SafflowerINACTIVE INGREDIENT4VBL71TY4Y3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I3
WaterINACTIVE INGREDIENT059QF0KO0R3
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-33963736-339-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE92RU3N3Y1OIACT
KUKUI NUT OILTP11QR7B8RIACT
ZINC PIDOLATEC32PQ86DH4IACT
PANTHENOLWV9CM0O67ZIACT
SAFFLOWER4VBL71TY4YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 StearatePEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
ndc (package): 63736-339-24
ndc (product): 63736-339
ndc11 (package): 63736033924
spl id: ee4d2862-849a-43e1-9e1d-e3b275740cad
spl set id: 0292ab62-5088-45fa-a056-70c2fcc19ef7

Reported adverse events (FAERS/openFDA)#

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