PSORIAFLORA- mahonia aquifolium root bark cream
Schwabe Mexico, S.A. de C.V.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Psoriaflora

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.

LBN21850990.A02 Z Psoriaflora Cream 1 oz.jpg

PSORIAFLORA
mahonia aquifolium root bark cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68466-1005-4	1 in 1 CARTON	01/01/2006	04/29/2022
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	04/29/2022

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

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

Revised: 4/2022

Document Id: 0c2eba6c-47e8-4d0c-9245-32b1ee4e4871

Set id: 8d2a4467-bf6d-49e5-a4e2-8b0d53811824

Version: 8

Effective Time: 20220420

Schwabe Mexico, S.A. de C.V.