Cortisone Cream

Manufacturer
Tai Guk Pharmaceutical Company, Limited
Effective date
2009-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:54:30

Label at a glance#

ProductCortisone Cream Intensive Healing
Active ingredientHydrocortisone
Label structure12 sections

Storage and handling

Other Information store at 15 0 to 25 0 C (59 0 to 77 0 F) Lot No. and Expiration Date see box or crimp of tube.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch


Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

WARNINGS SECTION

Warnings

  • for external use only
  • avoid contact with eyes

OTC - DO NOT USE SECTION

Do not use

  • if you have a vaginal discharge
  • for treating diaper rash
  • on children under 2 years of age

OTC - STOP USE SECTION

Stop using this product and ask a doctor

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

OTC - WHEN USING SECTION

When using this product

  • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor, do not begin the use of any other hydrocortisone product unless you have consulted a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Before using any medication, read all label directions. Keep this carton. It contains important information.

DOSAGE & ADMINISTRATION SECTION

Directions

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
For external anal itching

  • adults: when practical, cleanse affected area with mild soap and warm water and rinse thoroughly
  • by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other Information

  • store at 150 to 250 C (590 to 770 F)
  • Lot No. and Expiration Date see box or crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

BHA, cetyl alcohol, edetate disodium, glycerin, methylparaben, propylene glycol, propylparaben, purified lanolin, purified water, sodium benzoate, sodium lauryl sulfate, stearic acid, stearyl alcohol, trolamine, white petrolatum, xanthan gum.

OTC - QUESTIONS SECTION

Questions? Call toll-free 1-800-645-3867

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton label
Image of carton label
Image of tube label
Image of tube label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43136-819-712021-12-13C16284748780-1956f9ecf-cdce-621f-e053-dbdaa90a74adCortisone Cream (Intensive Healing)
43136-819-712019-10-21C16284748780-1956f9ecf-cdce-621f-e053-dbdaa90a74adCortisone Cream (Intensive Healing)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ4
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ4

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43136-81943136-819-71

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HydrocortisoneWI4X0X7BPJACTIB

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
8e14b065-b366-4abe-e053-2995a90af77f4e0637db-b17b-4b25-9718-afc0ca4343a02021-06-30WarningsExact identifier
spl set id: 4e0637db-b17b-4b25-9718-afc0ca4343a0

Reported adverse events (FAERS/openFDA)#

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