Psoriaflora Cream
FDA Label NDC 68466-2005

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 Mexico, S.a. De C.v. for the product Psoriaflora (NDC 68466-2005). 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 active ingredient, inactive ingredients, dosage & administration, indications & usage, purpose, warnings, do not use, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

* Please review the disclaimer below.