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Validerm Recall
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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History
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Other Information
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®.
Sources
Validerm Manufacturers
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Accumix Pharmaceuticals
Validerm | Accumix Pharmaceuticals
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.
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