FDA.reportPublic FDA data

ECOLAB Hydrocortisone Cream

Manufacturer
ECOLAB Food Safety Specialties, Inc. | Medique Products | Prestige Packaging
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:24:05

Label at a glance#

ProductECOLAB Hydrocortisone Cream
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy poison oak poison sumac cosmetics jewelry ​soaps detergents seborrheic dermatitis psoriasis Other uses of this product should be only under the advice and supervision of a doctor.

Dosage and administration

for 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

​Anti-itch

​Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations and rashes due to

eczema
insect bites
poison ivy
poison oak
poison sumac
cosmetics
jewelry
​soaps
detergents
seborrheic dermatitis
psoriasis

Other uses of this product 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

  • in the eyes
  • in large quantities
  • to treat a diaper rash
  • ​if you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and aska doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
  • a rash or other allergic reaction develops

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for 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

OTHER SAFETY INFORMATION

  • store at room temperature 59°-86°F (15°-30°C) (do not freeze)
  • tamper evident sealed packets
  • do not use any open or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-634-7680

ECOLAB 1% Hydrocortisone Cream Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.9g (1/32 oz) Packets

Reorder # 48

ECOLAB°

1% Hydrocortisone Cream

Temporary relief of itching associated with minor skin irritation, inflammation and rashes

25 Per Box

Hydrocortisone CreamHydrocortisone Cream

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
71338-14471338-144-73

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
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
alcohol3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
WHITE WAX7G1J5DA97FIACT

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
bcd0d3bb-391f-2942-e053-2995a90a50514b2f903a-668f-353a-e054-00144ff88e882021-03-05WarningsExact identifier
spl set id: 4b2f903a-668f-353a-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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