FDA.reportPublic FDA data

PSORIAFLORA

Manufacturer
Schwabe Mexico, S.A. de C.V.
Effective date
2022-04-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:02:54

Label at a glance#

ProductPSORIAFLORA
Active ingredientMAHONIA AQUIFOLIUM ROOT BARK
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Berberis aquifolium 2X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol

Cetyl Alcohol

Ethyl Alcohol

Glycol Stearate

Isopropyl Myristate

Mineral Oil

Potassium Hydroxide

Purified Water

Stearyl Heptanoate

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and Children 2 years of age and older: Apply to affected area up to 4 times daily. Rub in gently.

Children under 2 years of age: Consult a physician.

Patch test recommended on sensitive skin.

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves the dryness, itching, flaking, rash, redness and skin irritation associated with psoriasis.

Purpose

OTC - PURPOSE SECTION

Temporarily relieves the dryness, itching, flaking, rash, redness and skin irritation associated with psoriasis.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes or broken skin.

Do not use

OTC - DO NOT USE SECTION

Do not use if hypersensitive to any ingredients in this product.
Breast-feeding women should not apply to breast area.

Stop Use

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdosage

OVERDOSAGE SECTION

If swallowed, seek medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBN21850990.A02 Z Psoriaflora Cream 1 oz.jpgLBN21850990.A02 Z Psoriaflora Cream 1 oz.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68466-100568466-1005-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAHONIA AQUIFOLIUM ROOT BARKVZJ9F3C3SBACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
ALCOHOL3K9958V90MIACT
GLYCOL STEARATE0324G66D0EIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
STEARYL HEPTANOATE2M4UGL1NCNIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c2eba6c-47e8-4d0c-9245-32b1ee4e48718d2a4467-bf6d-49e5-a4e2-8b0d538118242022-04-20WarningsExact identifier
spl id: 0c2eba6c-47e8-4d0c-9245-32b1ee4e4871
spl set id: 8d2a4467-bf6d-49e5-a4e2-8b0d53811824

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.