Active Ingredient
Berberis aquifolium 2X
Psoriaflora Cream
- Manufacturer
- Schwabe North America, Inc | Schwabe Mexico, S.A. de C.V.
- Effective date
- 2025-08-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- full-release
- Hydrated at
- 2026-06-01 02:34:42
Label at a glance#
ProductPSORIAFLORA
Active ingredientMAHONIA AQUIFOLIUM ROOT BARK
Label structure12 sections
Label contents#
Full prescribing information#
Inactive Ingredient
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53499-1990-4 | PSORIAFLORA | 28 g in 1 TUBE | CREAM | 28 | 14 | |
| 53499-1990-4 | PSORIAFLORA | 1 in 1 CARTON | CREAM | 1 | 14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MAHONIA AQUIFOLIUM ROOT BARK | ACTIVE INGREDIENT | VZJ9F3C3SB | 4 | |
| MAHONIA AQUIFOLIUM ROOT BARK | ACTIVE MOIETY | VZJ9F3C3SB | 4 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 4 | |
| GLYCOL STEARATE | INACTIVE INGREDIENT | 0324G66D0E | 4 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 4 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 4 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 4 | |
| STEARYL HEPTANOATE | INACTIVE INGREDIENT | 2M4UGL1NCN | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 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 |
|---|---|
| 53499-1990 | 53499-1990-4 |
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#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCOL STEARATE | GLYCOL STEARATE | 0324G66D0E | CREAM / TOPICAL | 1 %w/w | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CREAM / TOPICAL | 0.5 %w/w | ||
| GLYCOL STEARATE | GLYCOL STEARATE | 0324G66D0E | CREAM / TOPICAL | 1 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CREAM / TOPICAL | 0.5 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg |
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 North America, Inc | 67f13a07-07c6-41ae-8ff4-29a105db43b2 | 2025-08-15 | Warnings | 53499-1990-4 53499-1990 53499199004 8a4c68a7-2f4d-4aad-9ac8-08d2c2890375 67f13a07-07c6-41ae-8ff4-29a105db43b2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.