FDA.reportPublic FDA data

ZCort

Manufacturer
RxDino, LLC | Accupack Midwest
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:53:58

Label at a glance#

ProductZCort Ultra
Active ingredientHYDROCORTISONE ACETATE
Label structure12 sections

Indications and uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: Eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Dosage and administration

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than...

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be 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
  • if pregnant or nursing - consult a doctor
  • in the genital area if you have a vaginal discharge - consult a doctor

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK A DOCTOR

OTC - STOP USE SECTION

  • if condition worsens or persists for more than 7 days
  • if condition clears up and occurs again
  • if rectal bleeding occurs
  • before using any other hydrocortisone product

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

FOR ITCHING OF SKIN IRRITATION, INFLAMMATION, AND RASHES

  • adults and children 12 years of age and older apply to affected area not more than 2 to 3 times daily

FOR EXTERNAL ANAL AND GENITAL ITCHING, ADULTS

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 2 to 3 times daily
  • Ages 12 to 18 years: ask a doctor

Other Information

OTHER SAFETY INFORMATION

Contents filled by weight, not volume

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadenis Leaf Extract, Cetearyl Alcohol, Cocos Nucifera Oil, Dehydroepiandrosterone (DHEA), Emulsifying Wax, Glycerin, Helianthus Annuus Seed Oil, Phenoxyethanol, Simmondsia Chinensis Seed Oil, Stearic Acid, Tocopherol, Water, Xanthan Gum

Front Display Panel and Back Card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

FORMULATED TO HEAL ITCH AND PROTECT COLLAGEN

STEROID POWER

FAST ACTING

  • Rash
  • Poison Ivy
  • Eczema
  • Insect Bites
  • Psoriasis
  • Inflammation

UNIQUE PATENTED FORMULA

ZCort ULTRA+ ANTI-ITCH CREAM

NET WT 0.5 OZ (15g)

ACTIVE INGREDIENT: HYDROCORTIZONE 1% WITH DHEA

see zcortfront.jpg

Front Display PanelFront Display Panel

ZCort Ultra+ ANTI-ITCH CREAM BACK CARD

see zcortbackbox.jpg

Back CardBack Card

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN6
106258hydrocortisone 10 MG/ML Topical CreamSCD6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY6
106258hydrocortisone 1 % Topical CreamSY6
106258hydrocortisone 1 GM per 100 GM Topical CreamSY6

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
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
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
81335-532-152023-01-10C16284748780-1e4f33bdf-a4ee-d8a0-e053-dadaa90a6e4eb68f8ada-58e8-e8e4-e053-2a95a90ab02d
81335-532-152022-07-29C16284748780-1e4f33bdf-a4ee-d8a0-e053-dadaa90a6e4eb68f8ada-58e8-e8e4-e053-2a95a90ab02d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81335-532-15ZCortUltra15 g in 1 BOXCREAM156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81335-532ZCORT ULTRA (HYDROCORTISONE ACETATE 1%) CREAM [RXDINO, LLC]6Current NDC, Legacy NDC, 1 package rows20250130_b68f8ada-58e8-e8e4-e053-2a95a90ab02d.zip

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
81335-53281335-532-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
PRASTERONE459AG36T1BIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 60CAL22UVI4MIACT
TOCOPHEROLR0ZB2556P8IACT
STEARIC ACID4ELV7Z65APIACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB

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
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
ndc (package): 81335-532-15
ndc (product): 81335-532
ndc11 (package): 81335053215
spl id: 2cddb6db-6b16-e67f-e063-6394a90a3cc6
spl set id: b68f8ada-58e8-e8e4-e053-2a95a90ab02d