NAZIREX COMPOUNDING KIT- levocetirizine dihydrochloride and loratadine
Alvix Laboratories, LLC

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.

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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

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

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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

Carton

NAZIREX COMPOUNDING KIT
levocetirizine dihydrochloride and loratadine kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:15455-9003

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15455-9003-9	1 in 1 CARTON; Type 0: Not a Combination Product

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)	LEVOCETIRIZINE DIHYDROCHLORIDE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 2 of 3

LORATADINE
loratadine powder, for suspension

Product Information
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	1 g in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Part 3 of 3

CREAM BASE
cream base suspension

Product Information
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERETH-20 (UNII: GJ57297I4F)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
STEARETH-2 (UNII: V56DFE46J5)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		54 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/18/2015	07/01/2015

Labeler - Alvix Laboratories, LLC (962445925)

Name	Address	ID/FEI	Business Operations
Establishment
Alvix Laboratories, LLC		962445925	repack(15455-9003)

Revised: 7/2015

Document Id: 1ae147f6-b554-63d4-e054-00144ff8d46c

Set id: 0d9eca3f-0a35-4783-bd81-c39cc35cf9da

Version: 2

Effective Time: 20150714

Alvix Laboratories, LLC