PSORIAFLORA- mahonia aquifolium root bark cream

PSORIAFLORA by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Berberis aquifolium 2X

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 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

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 or broken skin.

Do not use

Do not use if hypersensitive to any ingredients 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 immediately.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PSORIAFLORA 
mahonia aquifolium root bark cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-2005
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	2 [hp_X]  in 28 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
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: 68466-2005-4	1 in 1 CARTON	04/22/2022
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		04/22/2022

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(68466-2005)