RX-SPECIMEN COLLECTION KIT- specimen collection kit kit

Rx-Specimen Collection Kit by

Drug Labeling and Warnings

Rx-Specimen Collection Kit by is a Prescription medication manufactured, distributed, or labeled by MAS Management Group Inc., RxChange Co, Professional Disposable International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Rx Only

COMPONENTS

Kit Contains

1 x Furosemide 20mg Tablet

3 x Benzalkonium Chloride Towelettes

1 x Sterile Urine Collection Cup with Temperature Strip

1 x Specimen Bag

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DIAGRAM OF DEVICE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RX-SPECIMEN COLLECTION KIT 
specimen collection kit kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69677-030

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69677-030-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	07/23/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKAGE	1
Part 2	1 PACKET	3 mL

Part 1 of 2

FUROSEMIDE 
furosemide pill

Product Information
Item Code (Source)	NDC: 33358-0149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RE22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33358-0149-1	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078010	07/23/2015

Part 2 of 2

BENZALKONIUM CHLORIDE 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 10819-3740
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10819-3740-1	3 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078010	07/23/2015

Labeler - MAS Management Group Inc. (079363782)

Establishment
Name	Address	ID/FEI	Business Operations
MAS Management Group Inc.		079363782	manufacture(69677-030)

Establishment
Name	Address	ID/FEI	Business Operations
RxChange Co		781126805	manufacture(33358-0149)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposable International, Inc		800777117	manufacture(10819-3740)