FDA.reportPublic FDA data

First Aid Only Hydrocortisone 1% Anti-Itch Cream

Manufacturer
Acme United Corporation
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:16

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children over 2 years of age apply to affected area not more than 3 to 4 times daily children under 2, consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with minor skin irritations and rashes.

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use
  • in eyes
  • for diaper rash

OTC - STOP USE SECTION

Stop use and ask a doctor if

▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days

▪ you begin using other hydrocortisone products

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years of age

  • apply to affected area not more than 3 to 4 times daily
  • children under 2, consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Questions

OTC - QUESTIONS SECTION

1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Label Box LabelBox Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN2
106258hydrocortisone 10 MG/ML Topical CreamSCD2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2
106258hydrocortisone 1 % Topical CreamSY2
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-1133-00Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-01Hydrocortisone10 in 1 BOXCREAM102
0924-1133-01Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-02Hydrocortisone12 in 1 BOXCREAM122
0924-1133-02Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-03Hydrocortisone20 in 1 BOXCREAM202
0924-1133-03Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-04Hydrocortisone25 in 1 BOXCREAM252
0924-1133-04Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-05Hydrocortisone0.9 g in 1 POUCHCREAM0.92
0924-1133-05Hydrocortisone100 in 1 BOXCREAM1002
0924-1133-06Hydrocortisone144 in 1 BOXCREAM1442
0924-1133-06Hydrocortisone0.9 g in 1 POUCHCREAM0.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-1133HYDROCORTISONE CREAM [ACME UNITED CORPORATION]2Current NDC, 13 package rows20241115_fabcaa3b-d189-bd29-e053-6294a90ae86b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-11330924-1133-00, 0924-1133-01, 0924-1133-02, 0924-1133-03, 0924-1133-04, 0924-1133-05, 0924-1133-06
61010-5800

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
STEARETH-20L0Q8IK9E08IACT
HYDROCORTISONEWI4X0X7BPJACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
ndc (product): 61010-5800
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
ndc (package): 0924-1133-06
ndc (package): 0924-1133-02
ndc (package): 0924-1133-00
ndc (package): 0924-1133-04
ndc (package): 0924-1133-05
ndc (package): 0924-1133-01
ndc (package): 0924-1133-03
ndc (product): 0924-1133
ndc11 (package): 00924113303
ndc11 (package): 00924113304
ndc11 (package): 00924113300
ndc11 (package): 00924113302
ndc11 (package): 00924113305
ndc11 (package): 00924113301
ndc11 (package): 00924113306
spl id: 26bc4721-ef08-2542-e063-6394a90a5642
spl set id: fabcaa3b-d189-bd29-e053-6294a90ae86b

Reported adverse events (FAERS/openFDA)#

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