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Nazirex
  • Professionals
  • FDA PI

Nazirex

Generic name: levocetirizine dihydrochloride and loratadine
Dosage form: kit

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.

FOR PRESCRIPTION COMPOUNDING ONLY

DESCRIPTION

Each Nazirex Compounding Kit provides 3 grams of Levocetirizine Dihydrochloride USP, 3 grams of Loratadine USP, and 54 grams of Base. The resulting mixture is intended for topical use.

TO THE PHARMACIST:

Kit Components: 1 color coded light green bottle of 3g of Levocetirizine Dihydrochloride, 1 color coded sand bottle of 3g of Loratadine, and 1 bottle of 54g Base. Equipment needed: mill, spatula, mixing bowl, and Topi-Pump TM.

SIZE60 grams
NDC #15455-9003-9
Levocetirizine Dihydrochloride, USP3 grams
Loratadine, USP3 grams
Base54 grams

Prior to compounding, store Nazirex Compounding Kit at room temperature between 20 - 25 degrees C (68 - 77 degrees F). Protect from light.

Nazirex Compounding Kit components have a two-year expiration date.

For external use only. Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of product after 30 days of being compounded.

* Certificate of analysis on file.

The FDA has not approved Nazirex to cure, treat, or mitigate disease.

Nazirex is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only.

Rx ONLY

Alvix Laboratories, LLC
Ocean Springs, MS 39564
1(888)526-5449
www.Alvix.com

PRINCIPAL DISPLAY PANEL

NDC 15455-9003-9
RX ONLY

Nazirex Compounding Kit

Levocetirizine Dihydrochloride, USP ..... 3 grams

Loratadine, USP ..... 3 grams

Cream Base ..... 54 grams

FOR PRESCRIPTION COMPOUNDING ONLY
60 grams as dispensed