Indications and uses
for the temporary relief of itching associated with minor irritations and rashes Other uses of this product should be only under the advice and supervision of a doctor
71927-015 American Safety & First Aid Hydrocortisone Cream 1%
- Manufacturer
- Orazen Inc
- Effective date
- 2024-01-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:07:18
Label at a glance#
ProductAmerican Safety and First Aid
Active ingredientHYDROCORTISONE ACETATE
Label structure6 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: do not use
Label contents#
Full prescribing information#
Active Ingredient
Hydrocortisone Acetate 1%
Purpose
Anti-Itch Cream
Uses
- for the temporary relief of itching associated with minor irritations and rashes
- Other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do not use
for the treatment of diaper rash. Consult a doctor. Complete Warnings See Card or Box
Keep out of reach of children.
If swallowed contact a Poison Control Center right away.
Directions
- 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
Inactive Ingredients
Cetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water
Package Labeling:
DailyMed RxNorm Mappings#
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 |
|---|---|---|---|---|---|---|
| 71927-015-01 | American Safety and First Aid | 0.9 g in 1 POUCH | CREAM | 0.9 | 2 | |
| 71927-015-02 | American Safety and First Aid | 25 in 1 BOX | CREAM | 25 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- American Safety and First Aid
- HYDROCORTISONE ACETATE
- PETROLATUM
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- GLYCERYL 1-STEARATE
- ETHYLHEXYLGLYCERIN
- PHENOXYETHANOL
- GLYCERIN
- MINERAL OIL
- WATER
- HYDROCORTISONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71927-015 | 71927-015-01, 71927-015-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| GLYCERYL 1-STEARATE | 258491E1RZ | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCORTISONE ACETATE | 3X7931PO74 | 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 |
|---|---|---|---|---|---|---|
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | 71927-015-01 71927-015 71927001501 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | 71927-015-01 71927-015-02 71927-015 71927001502 71927001501 0efffe79-6b2c-8272-e063-6294a90a8f5a eb0cce4b-c70a-1b2d-e053-2995a90aa4aa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.