OTC - ACTIVE INGREDIENT SECTION
Hydrocortisone 1.0%
Cortibalm
- Manufacturer
- Dr. Dan's LLC
- Effective date
- 2019-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:09:04
Label at a glance#
ProductCortibalm
Active ingredientHYDROCORTISONE
Label structure4 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Beeswax, petroleum jelly, mineral oil.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67516-0108-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5bbc-a910-e053-dadaa90a0b85 | Cortibalm |
Products#
Every source-derived product name is available through these pages.
- Cortibalm
- Hydrocortisone Lip Balm
- MINERAL OIL
- HYDROCORTISONE
- PETROLATUM
- YELLOW WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67516-0108 | 67516-0108-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
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 |
|---|---|---|---|---|---|---|
| 93dc7087-f85e-3576-e053-2995a90a34d4 | 4e1390ae-644c-249c-e054-00144ff88e88 | 2019-10-01 | 93dc7087-f85e-3576-e053-2995a90a34d4 4e1390ae-644c-249c-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.