Drug Facts
Hydrocortisone Acetate USP (1 % W/W)
Hydrocortisone Acetate USP (1 % W/W)
Anti-Itch
for external use only
USES
If you are pregnant or breast- feeding
For Itching of skin irritation, inflammation and rashes:
Children under 2 years of age
For External anal and genital itching, adults:
Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69636-3050-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f40d-f424-e053-dadaa90a57ce | 2fbe9ae0-52d7-298a-e054-00144ff8d46c |
| 69636-3050-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f40d-f424-e053-dadaa90a57ce | 2fbe9ae0-52d7-298a-e054-00144ff8d46c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69636-3050-2 | Lincoln | 0.9 g in 1 PACKET | CREAM | 0.9 | 1 | |
| 69636-3050-3 | Lincoln | 28.3 g in 1 TUBE | CREAM | 28.3 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69636-3050 | LINCOLN (HYDROCORTISONE ACETATE) CREAM [LINCOLN PHARMACEUTICALS LTD.] | 1 | Legacy NDC, 2 package rows | 20160409_2fbe9ae0-52d7-298a-e054-00144ff8d46c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69636-3050 | 69636-3050-2, 69636-3050-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLOROCRESOL | 36W53O7109 | IACT |
| CETETH-20 | I835H2IHHX | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PROPYLENE GLYCOL 1,2-DISTEARATE | T65PN3O37H | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| HYDROCORTISONE ACETATE | 3X7931PO74 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 2fbe9ae0-52d8-298a-e054-00144ff8d46c | 2fbe9ae0-52d7-298a-e054-00144ff8d46c | 2016-04-05 | Warnings | 2fbe9ae0-52d8-298a-e054-00144ff8d46c 2fbe9ae0-52d7-298a-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.