FDA.reportPublic FDA data

Dermacort Anti-Itch Cream content of label

Manufacturer
Melaleuca, Inc.
Effective date
2011-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:12

Label at a glance#

ProductDermaCort Anti-Itch
Active ingredientHYDROCORTISONE
Label structure12 sections

Storage and handling

Other information do not store above 100°F (38°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose
Anti-itch

INDICATIONS & USAGE SECTION

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelry
  • other uses of this product should be only under the advice and supervision of a doctor

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use for the treatment of diaper rash. Ask a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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, ask a doctor.

STORAGE AND HANDLING SECTION

Other information do not store above 100°F (38°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients acrylates/C10-30 alkyl acrylates crosspolymer, cetyl alcohol, cyclopentasiloxane, deionized water, dimethicone, glycerin USP, glyceryl stearate and PEG-100 stearate, isopropyl palmitate, Melaleuca Oil, methylparaben, petrolatum USP, propylparaben, steareth-2, steareth-21, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of label
image of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
206354Dermacort 1 % Topical CreamPSN1
106258hydrocortisone 1 % Topical CreamPSN1
206354hydrocortisone 10 MG/ML Topical Cream [Dermacort]SBD1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
206354Dermacort 1 % Topical CreamSY1
206354Dermacort 10 MG/ML Topical CreamSY1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-117-012019-11-13C16284748780-197449f38-bf78-f6ea-e053-dbdaa90aa703Dermacort Anti-Itch Cream content of label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-117-01DermaCortAnti-Itch28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-117DERMACORT ANTI-ITCH (HYDROCORTISONE) CREAM [MELALEUCA, INC.]1Current NDC, Legacy NDC, 1 package rows20111122_a0962a88-8a49-414c-aecf-db94ec033f16.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT1G56KV7BUJ1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARETH-2INACTIVE INGREDIENTV56DFE46J51
STEARETH-21INACTIVE INGREDIENT53J3F32P581
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-11754473-117-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)1G56KV7BUJIACT
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
TEA TREE OILVIF565UC2GIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 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
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 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
STEARETH-2STEARETH-2V56DFE46J5CREAM / TOPICAL643 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 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
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 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
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5CREAM / TOPICAL643 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
ndc (product): 54473-117
d36aedc4-fb4f-43f0-bf9c-89593671db06a0962a88-8a49-414c-aecf-db94ec033f162011-11-09WarningsExact identifier
spl id: d36aedc4-fb4f-43f0-bf9c-89593671db06
spl set id: a0962a88-8a49-414c-aecf-db94ec033f16

Reported adverse events (FAERS/openFDA)#

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