PSORIAFLORA- mahonia aquifolium root bark cream

PSORIAFLORA by

Drug Labeling and Warnings

PSORIAFLORA by is a Otc medication manufactured, distributed, or labeled by Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Berberis aquifolium (Mahonia aquifolium 2X)

INACTIVE INGREDIENT

Inactive Ingredients:

BENZYL ALCOHOL

CETYL ALCOHOL

GLYCOL STEARATE

ISOPROPYL MYRISTATE

MINERAL OIL

POTASSIUM HYDROXIDE

WATER

STEARYL HEPTANOATE

DOSAGE & ADMINISTRATION

Dosage and Administration:

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 and Usage:

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

PURPOSE

Purpose:

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

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes or broken skin.

Do not use if hypersensitive to any ingredients in this product.

Breast-feeding women should not apply to breast area.

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.

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

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children:

Keep out of reach of children.

ASK DOCTOR

Ask the Doctor:

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 of regular use as directed.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

Pregnancy or Breast Feeding:

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

Breast-feeding women should not apply to breast area.

OVERDOSAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSORIAFLORA 
mahonia aquifolium root bark cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (MAHONIA AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	MAHONIA AQUIFOLIUM ROOT BARK	1 [hp_X]  in 28 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCOL STEARATE (UNII: 0324G66D0E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MINERAL OIL (UNII: T5L8T28FGP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68466-1005-4	1 in 1 CARTON	01/01/2006
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006

Labeler - Schwabe Mexico, S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(68466-1005)