Nuvya Cream

Generic name: tamoxifen citrate, adapalene and diclofenac sodium
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.

Nuvya Cream Description

NUVYA® is comprised of 100 mg of Tamoxifen Citrate USP, 150 mg of Adapalene USP, and 1 g of Diclofenac Sodium USP for dermatological use.1 NUVYA® 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 Tamoxifen Citrate, Adapalene and Diclofenac Sodium as contained in NUVYA®.

1

Certificate of analysis on file

Nuvya Cream Dosage and Administration

The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 50 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

NUVYA® 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 Nuvya Cream Supplied

NUVYA® Cream, as dispensed, is supplied as a four component package: three containers which contain the active components Tamoxifen Citrate USP 100 mg, Adapalene USP 150 mg and Diclofenac Sodium USP 1 g (respectively), a separate package of Cream Base and a stirring apparatus. The pharmacist must mix contents of each active component container with appropriate amount of Cream Base such that the QS volume yields 50 grams (final weight) at the time of dispensing. Pharmacist may utilize appropriate diluents ...