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  5. Label Information: Psoriaflora

FDA Label for Psoriaflora

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. OTC - PURPOSE
    6. WARNINGS
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - ASK DOCTOR
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OVERDOSAGE
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Psoriaflora Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient:

Berberis aquifolium (Mahonia aquifolium 10X)


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 doctor.

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.


Otc - 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.


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.


Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children:


Keep out of reach of children.


Otc - 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.


Otc - 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.


Package Label.Principal Display Panel



Packaging Label and Principal Display:

Boericke and Tafel Brand 21850990_PSORIAFLORA_05  1 oz tube


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