FDA.reportPublic FDA data

hydrocortisone

Manufacturer
CVS Pharmacy
Effective date
2018-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:45:38

Label at a glance#

Producthydrocortisone
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

• temporary relief of external anal itching • temporary relief of itching associated with minor skin irritations and rashes • other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

• adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product. • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily • children under 12 years of age: do not use, consult a doctor

Storage and handling

• store at 20-25 ° C (68-77 ° F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • 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

for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens
  • 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 unless you have consulted 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: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Relieves Itch Fast

EFFECTIVE RELIEF OF EXTERNAL ANAL ITCH

Compare to the active ingredient in Preparation H® Hydrocortisone 1% Cream

Anti-Itch Cream

Hydrocortisone 1%

RELIEVES EXTERNAL ITCH

NET WT 1 OZ (28 g)

7s4-hydrocortisone.jpg
7s4-hydrocortisone.jpg
7s4-hydrocortisone-2.jpg
7s4-hydrocortisone-2.jpg

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-62769842-627-64

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
ALOE VERA LEAFZY81Z83H0XIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL PALMITATE5ZA2S6B08XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT

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
edc44057-a19a-409e-acb9-7792ab607ed4dd73d62a-4ac2-4207-b034-5dd18523e1df2022-12-20WarningsExact identifier
spl set id: dd73d62a-4ac2-4207-b034-5dd18523e1df

Reported adverse events (FAERS/openFDA)#

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