NDC Code(s) : 0519-6264-41, 0519-6264-87, 0519-6264-13, 0519-6264-91
Packager : STERIS Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Kindest Kare Advanced Antimicrobial Foam HandwashBENZALKONIUM CHLORIDE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0519-6264
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE0.5 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-8 DIMETHICONE(UNII: GIA7T764OD)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
SORBITOL(UNII: 506T60A25R)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
COCO MONOISOPROPANOLAMIDE(UNII: 21X4Y0VTB1)
CETYL HYDROXYETHYLCELLULOSE (350000 MW)(UNII: T7SWE4S2TT)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)(UNII: 0L414VCS5Y)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE(UNII: H2KVQ74JM4)
COCAMIDOPROPYLAMINE OXIDE(UNII: M4SL82J7HK)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0519-6264-8712 in 1 CASE 15/06/2016
1NDC:0519-6264-411000 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0519-6264-9118 in 1 CASE 15/06/2016
2NDC:0519-6264-13444 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 06/15/2016

PRINCIPAL DISPLAY PANEL

Kindest Kare®
Advanced

Antimicrobial
Foam
Handwash

NDC 0519-6264-41

Hand Soap

Healthcare Personnel
Handwash

Moisturizing

Fragrance Free

REORDER #
6264-FM

1 Liter FSDS (33.8 fl oz) (1.05 qt)

STERIS ®

STERIS Corporation ■ 7501 Page Avenue ■ St. Louis, MO 63133 ■ USA
800-548-4873 ■ www.steris.com

62765
6264-X3B(F)(417)

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label