NDC Code(s) : 67777-245-01, 67777-245-11, 67777-245-02, 67777-245-14, 67777-245-04, 67777-245-15, 67777-245-05, 67777-245-06, 67777-245-16, 67777-245-08, 67777-245-18, 67777-245-07, 67777-245-17
Packager : Dynarex Corporation

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BZK PadsBenzalkonium Chloride SWAB
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-245
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67777-245-1110000 in 1 CASE 04/05/2011
1NDC:67777-245-01100 in 1 BOX
10.55 mL in 1 PACKET Type 0: Not a Combination Product
2NDC:67777-245-021000 in 1 BOX 30/03/2017
20.55 mL in 1 PACKET Type 0: Not a Combination Product
3NDC:67777-245-041000 in 1 CASE 04/05/2011
3NDC:67777-245-1410 in 1 BOX 30/03/2017
30.55 mL in 1 PACKET Type 0: Not a Combination Product
4NDC:67777-245-05750 in 1 CASE 04/05/2011
4NDC:67777-245-1525 in 1 BOX 30/03/2017
40.55 mL in 1 PACKET Type 0: Not a Combination Product
5NDC:67777-245-161000 in 1 CASE 04/05/2011
5NDC:67777-245-0610 in 1 BOX 30/03/2017
50.55 mL in 1 PACKET Type 0: Not a Combination Product
6NDC:67777-245-181000 in 1 CASE 04/05/2011
6NDC:67777-245-0840 in 1 BOX 30/03/2017
60.55 mL in 1 PACKET Type 0: Not a Combination Product
7NDC:67777-245-171000 in 1 CASE 04/05/2011
7NDC:67777-245-0750 in 1 BOX 30/03/2017
70.55 mL in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 04/05/2011

LABELER - Dynarex Corporation(008124539)

REGISTRANT - Dynarex Corporation(008124539)

PRINCIPAL DISPLAY PANEL

1303 BX MNFL0101303 Label

PRINCIPAL DISPLAY PANEL

1303 BX MASTER

PRINCIPAL DISPLAY PANEL

1331 MC MASTER1331

PRINCIPAL DISPLAY PANEL

1332 BX MASTER1332

PRINCIPAL DISPLAY PANEL

1333 BX MASTER1333

PRINCIPAL DISPLAY PANEL

1331 MC MNFL010

PRINCIPAL DISPLAY PANEL

1303UB-10_BX_MASTER1303UB-10

PRINCIPAL DISPLAY PANEL

1303-40_BX_MASTER1303-40

PRINCIPAL DISPLAY PANEL

1333-50_BX_MASTER1333-50