FDA.reportPublic FDA data

Hydrocortisone Cream

Manufacturer
medsource pharmaceuticals
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:39:20

Label at a glance#

ProductHydrocortisone Maximum Strength
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema      •insect bites      •poison ivy      •poison oak      •poison sumac      •soaps •jewelry      •detergents       •cosmetics       •psoriasis          •seborrheic dermatitis •for external genital, feminine and anal itching •other uses of this product should be only under the advice and supervision...

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   For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet issue or a soft cloth before application of this product Children under 12 year...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

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

•eczema      •insect bites      •poison ivy      •poison oak      •poison sumac      •soaps

•jewelry      •detergents       •cosmetics       •psoriasis          •seborrheic dermatitis

•for external genital, feminine and anal itching

•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 external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

•avoid contact with the eyes   •do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:   •do not use more than directed unless directed by a doctor   

•do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

•symptoms last for more than 7 days   •the condition gets worse   •symptoms clear up and occur again in a few days   •rectal bleeding occurs, consult doctor promptly

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

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, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet issue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
  • Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?  

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-630-012025-02-20C16284748780-12cef2736-aee4-d83d-e063-dadaa90ab31fHydrocortisone Cream
45865-630-012025-01-30C16284748780-12cef2736-aee4-d83d-e063-dadaa90ab31fHydrocortisone Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0343-56GM - Gram0472-03433c76f2f4-f0ef-4c3d-8d9b-4624fb9e295712012-07-24

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-63045865-630-01
0472-0343

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
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBIC ACIDX045WJ989BIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WHITE WAX7G1J5DA97FIACT
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
2e97b894-72f7-e6c8-e063-6394a90acd137df0b4dd-2798-e693-e053-2991aa0abacb2025-02-20WarningsExact identifier
spl set id: 7df0b4dd-2798-e693-e053-2991aa0abacb

Reported adverse events (FAERS/openFDA)#

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