First Aid Only Hydrocortisone 1% Anti-Itch Cream

Manufacturer: Acme United Corporation
Effective date: 2024-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 20:49:08

Label at a glance#

ProductHYDROCORTISONE

Active ingredientHYDROCORTISONE ACETATE

Label structure9 sections

Indications and 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; do not use, consult a doctor

Contacts and useful links#

PhonePoison Help(800-222-1222

PhoneLabel contact1.800.835.2263

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

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

Do not use ▪ in or near eyes

▪ for a diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes
do not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days
▪ symptoms clear up and occur again within a few days

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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; do not use, consult a doctor

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions ?

OTC - QUESTIONS SECTION

1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0924-5632	HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [ACME UNITED CORPORATION]	2	Legacy NDC	20241121_9a161e39-ce64-6399-e053-2a95a90ab36b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

HYDROCORTISONE
Anti-itch cream
EDETATE DISODIUM
LIGHT MINERAL OIL
STEARIC ACID
GLYCERYL MONOSTEARATE
POLYETHYLENE GLYCOL 10000
CETYL ALCOHOL
TROLAMINE
METHYLPARABEN
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
PROPYLPARABEN
GLYCERIN
WATER
HYDROCORTISONE ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0924-5632	0924-5632-03, 0924-5632-04, 0924-5632-01, 0924-5632-00, 0924-5632-02, 0924-5632-05, 0924-5632-06
59898-800

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
Name	UNII	Kind
EDETATE DISODIUM	7FLD91C86K	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
POLYETHYLENE GLYCOL 10000	H57W405143	IACT
CETYL ALCOHOL	936JST6JCN	IACT
TROLAMINE	9O3K93S3TK	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
HYDROCORTISONE ACETATE	3X7931PO74	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	ANTI-ITCH CREAM	Water-Jel Technologies	3d34ae31-265a-46bc-a52d-546ea5bb24b6	2025-12-31	Warnings	Exact identifier ndc (product): 59898-800
3802a816-73d6-2997-e063-6294a90a2177			9a161e39-ce64-6399-e053-2a95a90ab36b	2025-06-20	Warnings	Exact identifier spl set id: 9a161e39-ce64-6399-e053-2a95a90ab36b

Reported adverse events (FAERS/openFDA)#

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