Hydrocortisone Cream 1% Anti-Itch Cream

Manufacturer: Acme United Corporation | Acme United Crporation
Effective date: 2026-06-13
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: monthly-update
Hydrated at: 2026-07-17 21:37:11

Label at a glance#

ProductHydrocortisone 1% Anti-ItchCream

Active ingredientHYDROCORTISONE

Label structure9 sections

Indications and uses

temporarily relieves itching associated with minor skin irritations and rashes other uses of this product should only be 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: consult a doctor.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800.835.2263

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

(Anti-itch)

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor skin irritations and rashes
other uses of this product should only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Avoid Contact with the eyes

Do not use

OTC - DO NOT USE SECTION

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,

Stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor

.Do not use for the treatment of diaper rash. Consult 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 right away. (1-800-222-1222)

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: consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

store at room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-800.835.2263

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0092265074865	GTIN-13: 0092265074865 EAN-13: 0092265074865 GTIN-12: 092265074865 UPC-A: 092265074865 GTIN storage (14 digits): 00092265074865	807716-001-revA_FDA.jpg

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Hydrocortisone 1% Anti-ItchCream
HYDROCORTISONE
CETOSTEARYL ALCOHOL
GLYCERYL STEARATE SE
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE
PROPYLENE GLYCOL
WATER
STEARIC ACID
TROLAMINE
WHITE PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0924-5634	0924-5634-00, 0924-5634-02, 0924-5634-04
61040-229

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE	15O9QS218W	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
HYDROCORTISONE	WI4X0X7BPJ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone 1% Anti-ItchCream	HYDROCORTISONE	Acme United Corporation	5425fc2b-4f25-3e64-e063-6394a90aff49	2026-06-13	Warnings	Exact identifier ndc (package): 0924-5634-02 ndc (package): 0924-5634-00 ndc (package): 0924-5634-04 ndc (product): 0924-5634 ndc11 (package): 00924563400 ndc11 (package): 00924563402 ndc11 (package): 00924563404 spl id: 5425ff8d-cc9d-e5ef-e063-6294a90a585f spl set id: 5425fc2b-4f25-3e64-e063-6394a90aff49

Reported adverse events (FAERS/openFDA)#

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