570-3124 Hydrocortisone Cream 1% NDC 0404-0166-50

Manufacturer
Henry Schein
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-10 01:02:23

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

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: Consult a doctor • When using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor applying • Children under 12: Consult a doctor before using for anal itching

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone USP 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

Use(s)

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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Warnings

WARNINGS SECTION

For External Use Only

If pregnant or breastfeeding, ask a health professional before use

Do not use

OTC - DO NOT USE SECTION

• In the eyes

• For diaper rash

• For external genital or feminine itching if you have a vaginal discharge

• More than the recommended daily dosage unless directed by a doctor

• In the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer that 7 days

• In case of bleeding when used for anal itching

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 (1-800-222-1222) 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: Consult a doctor

• When using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor applying

• Children under 12: Consult a doctor before using for anal itching

Other Information

OTHER SAFETY INFORMATION

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HS-570-3124 BX MASTERHS-570-3124 BX MASTERHydrocortisone Cream 1%

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130304040166505GTIN-13: 0304040166505
EAN-13: 0304040166505
GTIN-12: 304040166505
UPC-A: 304040166505
GTIN storage (14 digits): 00304040166505
HS-570-3124 BX MASTER (R220726-1).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-01660404-0166-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-11-25full-release2026-06-01 01:18:12

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEHenry Scheineb031535-d17e-9d5e-e053-2a95a90ad3e02025-11-25WarningsExact identifier
ndc (package): 0404-0166-50
ndc (product): 0404-0166
ndc11 (package): 00404016650
spl set id: eb031535-d17e-9d5e-e053-2a95a90ad3e0

Reported adverse events (FAERS/openFDA)#

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