Otc - Active Ingredient
Active Ingredient:
Berberis aquifolium (Mahonia aquifolium 10X)
Psoriaflora Cream
FDA Label NDC 53499-1990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Psoriaflora (NDC 53499-1990). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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