Validerm Cream

Generic name: calcitriol, fluticasone propionate and tacrolimus
Dosage form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Validerm Cream Description

VALIDERM® is comprised of 0.2 mg of Calcitriol USP, 50 mg of Fluticasone Propionate USP, and 50 mg of Tacrolimus USP for dermatological use.1 VALIDERM® also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Calcitriol, Fluticasone Propionate and Tacrolimus comparable to the active ingredients (Vectical® 3mcg/g, Cutivate® 0.05%, and Protopic® 0.1%) contained in VALIDERM®. 2

1

Certificate of analysis on file

2

This product is not manufactured by Galderma Labs LP, manufacturer of Vectical®, GlaxoSmithKline, manufacturer of Cutivate®, or by Astellas Pharma US, Inc., manufacturer of Protopic®.

Validerm Cream Dosage and Administration

The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 100 grams at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. For dermatological use only. This product should not be administered orally.

Contraindications

VALIDERM® Topical Cream, as dispensed, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

USES

Consult your pharmacist.

HOW TO USE

Consult your pharmacist.

Precautions

Consult your pharmacist.

Drug Interactions

Consult your pharmacist. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

SIDE EFFECTS

Consult your pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

MISSED DOSE

Consult your pharmacist.

NOTES

No Monograph available at this time.

How is Validerm Cream Supplied

VALIDERM® Cream, as dispensed, is supplied as a five component package: three containers which contain ...