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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.

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)
Alvix Laboratories, LLC