Rx-Specimen Collection Kit

Rx Only

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.

specimen cup

image description

RX-SPECIMEN COLLECTION KIT
specimen collection kit kit

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

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

Part 1 of 2

FUROSEMIDE
furosemide pill

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Part 2 of 2

BENZALKONIUM CHLORIDE
benzalkonium chloride swab

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

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

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

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

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

Labeler - MAS Management Group Inc. (079363782)

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

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

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