FDA.reportPublic FDA data

First Aid Only Hydocortisone 1% Anti-Itch Cream

Manufacturer
Acme United Corporation | Acme United Corpoation
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:09

Label at a glance#

ProductFirst Aid Only Hydrocortisone 1% Anti-Itch
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

Uses ▪ temporarily relieves itching associated with minor skin irritations and rashes ▪other uses 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

Storage and handling

Store at 15° to 30°C (59° to 86°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

PURPOSE

OTC - PURPOSE SECTION

Anti-Itch

USES

INDICATIONS & USAGE SECTION

Uses ▪ temporarily relieves itching associated with minor skin irritations and rashes

▪other uses 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 a diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not begin use of any other Hydrocortisone product unless you have asked a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed get medical help or contact poison control (800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin

SPL UNCLASSIFIED SECTION

Questions 1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton image Carton ImageCarton Image

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
0924-5633-00First Aid Only Hydrocortisone 1% Anti-Itch0.9 g in 1 PACKETCREAM0.92
0924-5633-01First Aid Only Hydrocortisone 1% Anti-Itch0.9 g in 1 PACKETCREAM0.92
0924-5633-01First Aid Only Hydrocortisone 1% Anti-Itch12 in 1 CARTONCREAM122
0924-5633-02First Aid Only Hydrocortisone 1% Anti-Itch25 in 1 CARTONCREAM252
0924-5633-02First Aid Only Hydrocortisone 1% Anti-Itch0.9 g in 1 PACKETCREAM0.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5633FIRST AID ONLY HYDROCORTISONE 1% ANTI-ITCH (HYDROCORTISONE) CREAM [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 5 package rows20241121_e5597b11-b08e-99e1-e053-2a95a90a15a5.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-56330924-5633-01, 0924-5633-00, 0924-5633-02
50382-024

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
CHLOROCRESOL36W53O7109IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
ndc (package): 0924-5633-01
ndc (package): 0924-5633-02
ndc (package): 0924-5633-00
ndc (product): 0924-5633
ndc11 (package): 00924563301
ndc11 (package): 00924563302
ndc11 (package): 00924563300
spl id: 274ab3c8-05bc-6f35-e063-6294a90a306e
spl set id: e5597b11-b08e-99e1-e053-2a95a90a15a5

Reported adverse events (FAERS/openFDA)#

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