Storage and handling
Other information Do not store above 100°F.
DermaCort
- Manufacturer
- Melaleuca, Inc.
- Effective date
- 2025-03-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:58:43
Label at a glance#
ProductDermaCort Anti-itch
Active ingredientHYDROCORTISONE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Hydrocortisone 1%
OTC - PURPOSE SECTION
Purpose
Anti-itch
INDICATIONS & USAGE SECTION
Uses
- For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, psoriasis, , seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelery
- Other use of this product should be only under the advice and supervision of a doctor.
WARNINGS SECTION
Warnings
For external use only.
OTC - WHEN USING SECTION
When using this product avoid contact with the eyes.
OTC - STOP USE SECTION
Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
OTC - DO NOT USE SECTION
Do not use for the treatment of diaper rash. Consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
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, consult a doctor.
STORAGE AND HANDLING SECTION
Other information Do not store above 100°F.
INACTIVE INGREDIENT SECTION
Inactive ingredients Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Cetyl Alcohol, Cyclopentasiloxane, Deionized Water, Dimethicone, Glycerin USP, Glyceryl Stearate and PEG-100 Stearate, Isopropyl Palmitate, Melaleuca Oil, Methylparaben, Petrolatum USP, Propylparaben, Serareth-2, Steareth-21, Triethanolamine.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 206354 | Dermacort 1 % Topical Cream | PSN | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 6 |
| 206354 | hydrocortisone 10 MG/ML Topical Cream [Dermacort] | SBD | 6 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 6 |
| 206354 | Dermacort 1 % Topical Cream | SY | 6 |
| 206354 | Dermacort 10 MG/ML Topical Cream | SY | 6 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 6 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 6 |
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 |
|---|---|---|---|---|---|
| 54473-117-28 | 2025-04-07 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
| 54473-117-28 | 2025-01-30 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
| 54473-117-28 | 2023-05-22 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
| 54473-117-28 | 2022-01-28 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
| 54473-117-28 | 2020-03-19 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
| 54473-117-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f9aa-f424-e053-dadaa90a57ce | DermaCort |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54473-117-28 | DermaCortAnti-itch | 28 g in 1 TUBE | CREAM | 28 | 6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DermaCort Anti-itch
- Hydrocortisone
- POLYOXYL 100 STEARATE
- PROPYLPARABEN
- STEARETH-2
- STEARETH-21
- TEA TREE OIL
- TROLAMINE
- WATER
- CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CETYL ALCOHOL
- CYCLOMETHICONE 5
- DIMETHICONE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- ISOPROPYL PALMITATE
- METHYLPARABEN
- PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54473-117 | 54473-117-28 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| DermaCort Anti-itch | HYDROCORTISONE | Melaleuca, Inc. | 24044b0f-dd1e-4762-82b8-7a28b08c2f77 | 2025-03-20 | Warnings | 54473-117-28 54473-117 54473011728 30cddb97-469e-d4b1-e063-6394a90a098b 24044b0f-dd1e-4762-82b8-7a28b08c2f77 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.