ProStat First Aid Hydrocortisone Cream 1% MAXIMUM STRENGTH

Manufacturer
ProStat First Aid | Trifecta Pharmaceuticals USA LLC
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:05

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 ● external feminine, genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor

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 and anal 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...

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

● external feminine, genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Do Not Use

OTC - DO NOT USE SECTION

  • For the treatment of diaper rash, consult a doctor.
  • With any other Hydrocortisone product unless you have consulted a doctor
  • If you have a vaginal discharge, consult 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 the rectum by using fingers or any 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 and anal 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

Distrubuted for

ProStat First Aid

La Verne CA 91750

Part No 2045

Questions

OTC - QUESTIONS SECTION

Call 1-888-900-2920

M-F 8AM - 4PM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PS_2045_HYDROCORTISIONE CREAM 0.9G 25PK BOX_123025 CDERPS_2045_HYDROCORTISIONE CREAM 0.9G 25PK BOX_123025 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889010179GTIN-13: 0814889010179
EAN-13: 0814889010179
GTIN-12: 814889010179
UPC-A: 814889010179
GTIN storage (14 digits): 00814889010179
PS_2045_HYDROCORTISONE CREAM 0.9G 25PK BOX_123025 CDER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-7030-1Hydrocortisone 1%25 in 1 BOXCREAM251
58228-7030-1Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.91

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
58228-703058228-7030-1

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
ndc (package): 58228-7030-1
ndc (product): 58228-7030
ndc11 (package): 58228703001
spl id: 4cd61b95-3b80-662f-e063-6394a90a9577
spl set id: 4cd62cba-075a-7448-e063-6394a90ab48d

Reported adverse events (FAERS/openFDA)#

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