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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.

Nazirex Compounding Kit

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.

SIZE 60 grams
NDC # 15455-9003-9
Levocetirizine Dihydrochloride, USP 3 grams
Loratadine, USP 3 grams
Base 54 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

Nazirex COMPOUNDING KIT 
levocetirizine dihydrochloride and loratadine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15455-9003
Packaging
# Item Code Package Description
1 NDC:15455-9003-9 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS 3 g
Part 2 1 BOTTLE, GLASS 3 g
Part 3 1 BOTTLE, PLASTIC 54 g
Part 1 of 3
LEVOCETIRIZINE DIHYDROCHLORIDE 
levocetirizine dihydrochloride powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 1 g  in 1 g
Packaging
# Item Code Package Description
1 3 g in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 2 of 3
LORATADINE 
loratadine powder, for suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 1 g  in 1 g
Packaging
# Item Code Package Description
1 3 g in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Part 3 of 3
CREAM BASE 
cream base suspension
Product Information
     
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
ALOE VERA LEAF  
ALLANTOIN  
BUTYLPARABEN  
DIAZOLIDINYL UREA  
EDETATE DISODIUM  
ETHYLPARABEN  
GLYCERETH-20  
GLYCERETH-26  
GLYCERIN  
ISOPROPYL MYRISTATE  
LECITHIN, SOYBEAN  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
MINERAL OIL  
CERESIN  
PANTHENOL  
PHENOXYETHANOL  
POLYSORBATE 20  
POLOXAMER 407  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
SODIUM BENZOATE  
SORBIC ACID  
STEARETH-2  
TITANIUM DIOXIDE  
TROLAMINE  
WATER  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 54 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/18/2015
Labeler - Alvix Laboratories, LLC (962445925)
Revised: 03/2015
 
Alvix Laboratories, LLC



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