PSORIAFLORA (MAHONIA AQUIFOLIUM ROOT BARK) CREAM [SCHWABE NORTH AMERICA, INC]

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PSORIAFLORA (MAHONIA AQUIFOLIUM ROOT BARK) CREAM [SCHWABE NORTH AMERICA, INC]
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NDC 53499-1990-4
Set ID 67f13a07-07c6-41ae-8ff4-29a105db43b2
Category HUMAN OTC DRUG LABEL
Packager Schwabe North America, Inc
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredient

    Berberis aquifolium 2X

  • 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 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

    LBN21850990.A02 Z Psoriaflora Cream 1 oz.jpg

  • INGREDIENTS AND APPEARANCE
    PSORIAFLORA 
    mahonia aquifolium root bark cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (MAHONIA AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) MAHONIA AQUIFOLIUM ROOT BARK2 [hp_X]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-1990-41 in 1 CARTON01/01/2006
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2006
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-1990)
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