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
ProStat First Aid Hydrocortisone Cream 1% MAXIMUM STRENGTH
- Manufacturer
- ProStat First Aid | Trifecta Pharmaceuticals USA LLC
- Effective date
- 2026-03-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:16
Label at a glance#
ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure14 sections
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.
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.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Hydrocortisone 1%
Purpose
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
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
Do Not Use
- For the treatment of diaper rash, consult a doctor
- If you have a vaginal discharge, consult a doctor
Warnings
For external use only
When using this product
- Avoid Contact with the eyes
- do not exceed the recommended daily dosage unless directed by a doctor.
Stop using this product and ask a doctor if
- 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
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.
Inactive ingredients
Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.
Other information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Tamper evident, do not use if packet is torn, cut or opened.
Distributed By
Distrubuted for
ProStat First Aid
La Verne CA 91750
Part No 2045
Questions
Call 1-888-900-2920
M-F 8AM - 4PM
Packaging
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58228-7020-1 | Hydrocortisone 1% | 0.9 g in 1 PACKET | CREAM | 0.9 | 1 | |
| 58228-7020-1 | Hydrocortisone 1% | 2000 in 1 CASE | CREAM | 2000 | 1 |
Products#
Every source-derived product name is available through these pages.
- Hydrocortisone 1%
- Hydrocortisone
- PHENOXYETHANOL
- MINERAL OIL
- GLYCERIN
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- ETHYLHEXYLGLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58228-7020 | 58228-7020-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | 58228-7020-1 58228-7020 58228702001 4e53e197-b509-a1f2-e063-6394a90a49c4 4e53d29c-ed3c-f481-e063-6294a90a3181 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.