ACTIVE-MEDICATED SPECIMEN COLLECTION KIT- urine specimen collection kit
Pharmaceutica North America, Inc

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Active-Medicated Specimen Collection Kit

Contents not for individual sale

For professional use only

Each Kit contains:

1x furosemide 20mg tablet

3x benzalkonium choloride toweletts

1x sterile urine collection cup w/ temperature strip

1x specimen bag

Keep out of reach of children

image description

ACTIVE-MEDICATED SPECIMEN COLLECTION KIT
urine specimen collection kit kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:45861-107

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45861-107-01	1 in 1 PACKAGE

Part 1 of 3

STERILE URINE COLLECTION CUP WITH TEMPERATURE STRIP
device, specimen collection

Product Information
Item Code (Source)	NHRIC:49430-0001

Product Characteristics
number of times usable	1

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	ABC	10/31/2013

Part 2 of 3

FUROSEMIDE
furosemide tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (FUROSEMIDE)	FUROSEMIDE	20 mg

Ingredient Name	Strength
Inactive Ingredients
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
SODIUM STARCH GLYCOLATE TYPE A CORN

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-097-01	1 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078010	10/31/2013

Part 3 of 3

BENZALKONIUM CHLORIDE
benzalkonium chloride swab

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (BENZALKONIUM)	BENZALKONIUM CHLORIDE	0.0013 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		3 mL in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/31/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078010	10/31/2013

Labeler - Pharmaceutica North America, Inc (962739699)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals		010632300	manufacture(68071-097)

Name	Address	ID/FEI	Business Operations
Establishment
Professional Disposable International, Inc		800777117	manufacture(10819-3737)

Revised: 12/2013

Document Id: c0bba7b5-c9bf-425b-b0fa-c29793b2ca27

Set id: 0454f6f8-6fd1-46da-bc48-4b7849689a29

Version: 5

Effective Time: 20131210

Pharmaceutica North America, Inc