FDA.reportPublic FDA data

First Aid Only Anti-Itch Cream - Acme United Corporation

Manufacturer
Acme United Corporation
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-06 02:03:18

Label at a glance#

ProductFirst Aid Only Anti-Itch Cream
Active ingredientHYDROCORTISONE
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 of age: Do not use, consult a doctor

Storage and handling

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

Label contents#

Full prescribing information#

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 should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with the eyes.

Stop use and consult a doctorif condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days; do not begin use of any other hydrocortisone product.

Do not use for the treatment of diaper rash. Consult a doctor.

Keep out of reach of children. If swallowed get medical help or contact poison control 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 room temperature 68-77°F (20-25°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, water, white petrolatum

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact poison control right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-56380924-5638-00
43473-054

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
CETEARETH-20YRC528SWUYIACT
CETEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact identifier
ndc (product): 43473-054

Reported adverse events (FAERS/openFDA)#

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