Front Line Safety Hydrocortisone Cream USP 1%

Manufacturer
ProStat First Aid | Trifecta Pharmaceuticals USA LLC
Effective date
2026-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-16 01:01:57

Label at a glance#

ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure14 sections

Indications and uses

For 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 for external genital, feminine and anal itching

Dosage and administration

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use and ask a doctor. For external anal and genital itching in adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or a soft cloth before applying For External anal and genital...

Storage and handling

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F) Tamper evident, do not use if packet is torn, cut or opened. avoid excessive heat and humidity.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

Uses

INDICATIONS & USAGE SECTION

For 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

for external genital, feminine and anal itching

Do Not Use

OTC - DO NOT USE SECTION

  • For the treatment of diaper rash, consult a doctor
  • If you have a vaginal discharge, consult a doctor
  • with any other hydrocortisone product unless you have consulted a doctor

Warnings

WARNINGS SECTION

For external use only

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 this product into rectum by using fingers, mechanical device or applicator.

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product.
  • Rectal bleeding occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use and ask a doctor.

For external anal and genital itching in adults:

  • When practical, clean affected area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before applying

For External anal and genital itching in children under 12 years of age; ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.

Other information

STORAGE AND HANDLING SECTION

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Tamper evident, do not use if packet is torn, cut or opened.

avoid excessive heat and humidity.

Distributed By

SPL UNCLASSIFIED SECTION

Manufactured for Front Line Safety

La Verne CA 91750

Part No 2045

Questions

OTC - QUESTIONS SECTION

Call 1-888-900-2920

M-F 8AM - 4PM PST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FL2045 HYDROCORTISONE CREAM 0.9G 25PK BOX 123025 CDERFL2045 HYDROCORTISONE CREAM 0.9G 25PK BOX 123025 CDER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889014894GTIN-13: 0814889014894
EAN-13: 0814889014894
GTIN-12: 814889014894
UPC-A: 814889014894
GTIN storage (14 digits): 00814889014894
FL2045 HYDROCORTISONE CREAM 0.9G 25PK BOX 123025 CDER.jpg

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
58228-709058228-7090-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 19 · 369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsName fallback
generic name: HYDROCORTISONE
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsName fallback
generic name: HYDROCORTISONE
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsName fallback
generic name: HYDROCORTISONE
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsName fallback
generic name: HYDROCORTISONE
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsName fallback
generic name: HYDROCORTISONE
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsName fallback
generic name: HYDROCORTISONE
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESolco Healthcare LLC04f112e5-ec88-46c8-b675-8b4e38a86ab42026-08-11Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsName fallback
generic name: HYDROCORTISONE
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-08-03Adverse reactionsName fallback
generic name: HYDROCORTISONE
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsName fallback
generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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