Active Ingredient
Berberis aquifolium 2X
PSORIAFLORA
- Manufacturer
- Schwabe Mexico, S.A. de C.V.
- Effective date
- 2025-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:34:40
Label at a glance#
ProductPSORIAFLORA
Active ingredientMAHONIA AQUIFOLIUM ROOT BARK
Label structure12 sections
Label contents#
Full prescribing information#
Inactive Ingredients
Benzyl Alcohol
Cetyl Alcohol
Ethyl Alcohol
Glycol Stearate
Isopropyl Myristate
Mineral Oil
Potassium Hydroxide
Purified Water
Stearyl Heptanoate
Dosage & Administration
Directions:
Adults and children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently.
Patch test recommended on sensitive skin.
Indications & Usage
Temporarily relieves the dryness, itching, flaking, rash, redness, and skin irritation associated with psoriasis.
Purpose
Temporarily relieves the dryness, itching, flaking, rash, redness, and skin irritation associated with psoriasis.
Warnings
For external use only.
Avoid contact with eyes and broken skin.
Do not use
Do not use if hypersensitive to this or any other ingredient in this product.
Breast-feeding women should not apply to breast area.
Stop Use
Stop use and ask a doctor if increased skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days.
These could be signs of a serious condition.
Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep out of reach of children
Keep out of reach of children.
Overdosage
If swallowed, seek medical help or contact a Poison Control Center right away.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68466-2005-4 | PSORIAFLORA | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 68466-2005-4 | PSORIAFLORA | 28 g in 1 TUBE | CREAM | 28 | 4 |
Products#
Every source-derived product name is available through these pages.
- PSORIAFLORA
- MAHONIA AQUIFOLIUM ROOT BARK
- BENZYL ALCOHOL
- CETYL ALCOHOL
- ALCOHOL
- GLYCOL STEARATE
- ISOPROPYL MYRISTATE
- MINERAL OIL
- POTASSIUM HYDROXIDE
- WATER
- STEARYL HEPTANOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68466-2005 | 68466-2005-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAHONIA AQUIFOLIUM ROOT BARK | VZJ9F3C3SB | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| GLYCOL STEARATE | 0324G66D0E | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARYL HEPTANOATE | 2M4UGL1NCN | 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 |
|---|---|---|---|---|---|---|
| PSORIAFLORA | MAHONIA AQUIFOLIUM ROOT BARK | Schwabe Mexico, S.A. de C.V. | 2e49d7cd-ef79-4a74-92b9-5e994e71d9c8 | 2025-08-15 | Warnings | 68466-2005-4 68466-2005 68466200504 173eb54e-2c4a-45df-91bb-571facefc544 2e49d7cd-ef79-4a74-92b9-5e994e71d9c8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.