NDC Code(s) : 53329-178-04, 53329-178-08, 53329-178-06, 53329-178-84, 53329-178-25
Packager : Medline Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CleanseBenzalkonium Chloride 0.13% SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53329-178
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
MYRISTAMIDOPROPYLAMINE OXIDE(UNII: 3HSF539C9T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE(UNII: YM0K64F20V)
EDETATE SODIUM(UNII: MP1J8420LU)
CETRIMONIUM CHLORIDE(UNII: UC9PE95IBP)
GLYCERIN(UNII: PDC6A3C0OX)
LAURAMIDOPROPYLAMINE OXIDE(UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE(UNII: C80684146D)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SODIUM SULFATE ANHYDROUS(UNII: 36KCS0R750)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53329-178-04118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/2015
2NDC:53329-178-08221 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/2015
3NDC:53329-178-06273 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/2015
4NDC:53329-178-841000 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product19/08/2015
5NDC:53329-178-253790 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/19/2015 12/31/2018

PRINCIPAL DISPLAY PANEL

CLEANSE ANTIBACTERIAL HAND SOAP

  • Helps kill harmful germs
  • Gentle enough for everyday use

Representative container label