NDC Code(s) : 0519-1181-41, 0519-1181-87, 0519-1181-13, 0519-1181-91, 0519-1181-03, 0519-1181-52, 0519-1181-25, 0519-1181-67
Packager : STERIS Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cal Stat Plus Antiseptic Handrub Isopropyl Alcohol LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0519-1181
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Isopropyl Alcohol(UNII: ND2M416302)
(Isopropyl Alcohol - UNII:ND2M416302) 		Isopropyl Alcohol63 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
methylpropanediol(UNII: N8F53B3R4R)
phenoxyethanol(UNII: HIE492ZZ3T)
lactic acid(UNII: 33X04XA5AT)
glycerin(UNII: PDC6A3C0OX)
hydroxypropyl cellulose (type H)(UNII: RFW2ET671P)
polyquaternium-6 (150000 MW)(UNII: 163BBM0B4X)
behentrimonium methosulfate(UNII: 5SHP745C61)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0519-1181-8712 in 1 CASE
1NDC:0519-1181-411000 mL in 1 BOTTLE
2NDC:0519-1181-9118 in 1 CASE
2NDC:0519-1181-13444 mL in 1 BOTTLE
3NDC:0519-1181-5272 in 1 CASE
3NDC:0519-1181-03118 mL in 1 BOTTLE
4NDC:0519-1181-6796 in 1 CASE
4NDC:0519-1181-2559 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 03/18/2011

PRINCIPAL DISPLAY PANEL

Cal Stat® Plus

NDC 0519-1181-41

Antiseptic Handrub
with Enhanced
Emollients

Hand Sanitizer

Excellent
Moisturization

15
seconds
Fast-acting

CHG Compatible

For Hospital and Professional Use Only.
1 Liter SDS (33.8 fl oz) (1.05 qt)

STERIS®

REORDER #
1181-87

1181-86F(F)(1013)
61959

Principal Display Panel - 1 Liter Bottle Label