NDC Code(s) : 54057-400-40, 54057-400-42
Packager : Afflink, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AFFEX Antibacterial Plum Foam HandwashBenzalkonium Chloride LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54057-400
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.005 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
PEG-80 SORBITAN LAURATE(UNII: 239B50Y732)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)(UNII: PI1STR9QYH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54057-400-401200 mL in 1 PACKAGE Type 0: Not a Combination Product30/04/2017
2NDC:54057-400-421250 mL in 1 PACKAGE Type 0: Not a Combination Product30/04/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug 505G(a)(3) 04/30/2017

LABELER - Afflink, Inc.(023121150)

PRINCIPAL DISPLAY PANEL

Product Label