Dosage and administration
Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily Children under 2 years of age: Do not use
81552-003 Hydrocortisone Cream
- Manufacturer
- ROOSIN MEDICAL CO., LTD
- Effective date
- 2021-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:45:41
Label at a glance#
ProductRoosin
Active ingredientHYDROCORTISONE ACETATE
Label structure8 sections
Storage and handling
Store at room temperature
Label contents#
Full prescribing information#
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-Itch
Use
Temporary relieves itching associated with minor irritations and rashes
Other uses should be only under the advice and supervision of a doctor
WARNINGS
For external use only
OTC - DO NOT USE SECTION
Do not use
- In or near eyes
- For diaper rash, consult a doctor
OTC - WHEN USING SECTION
When using this product
- Do not use any other hydrocortisone products unless you have contacted a doctor
OTC - STOP USE SECTION
Stop use and ask a doctor if
Condition worsens or persists for more than 7 days
Symptoms clear up and occur within a few days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If ingested, get medical help or contact a poison control center right away
Directions
Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily
Children under 2 years of age: Do not use
Inactive ingredients
Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water
Other Information
Store at room temperature
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81552-003-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-217f-0266-e053-dadaa90a7c1a | 81552-003 Hydrocortisone Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81552-003-01 | Roosin | 0.9 g in 1 TUBE | CREAM | 0.9 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Roosin
- HYDROCORTISONE ACETATE
- PETROLATUM
- PARAFFIN
- OCTADECANOL (MIXTURE OF ISOMERS)
- WATER
- STEARIC ACID
- GLYCEROL FORMAL
- HYDROCORTISONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81552-003 | 81552-003-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| OCTADECANOL (MIXTURE OF ISOMERS) | C6BPY2QY39 | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| GLYCEROL FORMAL | 3L7GR2604E | 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 |
|---|---|---|---|---|---|---|
| d3325152-47bb-d0af-e053-2a95a90aa916 | e8154890-eb2f-42c1-a594-9f2a40424b04 | 2021-12-15 | Warnings | d3325152-47bb-d0af-e053-2a95a90aa916 e8154890-eb2f-42c1-a594-9f2a40424b04 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.