NDC Code(s) : 0519-1206-13, 0519-1206-87, 0519-1206-41, 0519-1206-91
Packager : STERIS Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acute-Kare CHLOROXYLENOL SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0519-1206
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q) 		CHLOROXYLENOL1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE(UNII: 632GS99618)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
DISODIUM COCOAMPHODIACETATE(UNII: 18L9G3U51M)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)(UNII: 0L414VCS5Y)
EDETATE SODIUM(UNII: MP1J8420LU)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER(UNII: 39DK5WQ2PR)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0519-1206-8718 in 1 CASE
1NDC:0519-1206-13444 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0519-1206-9112 in 1 CASE
2NDC:0519-1206-411000 mL in 1 BOTTLE 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 01/17/1995

PRINCIPAL DISPLAY PANEL

NDC 0519-1206-41

ACUTE-KARE®

Healthcare Personnel Handwash

Net Contents: 1 Liter SDS (33.8 fl oz) (1.05 qt)
1206-87

ANTIMICROBIAL

For Hospital and Professional Use Only

STERIS Corporation ■ 7501 Page Avenue ■ St. Louis, MO 63133 ■ USA
www.steris.com ■ Product Made in U.S.A.

STERIS®

1206-86H(113)

61084

Principal Display Panel - 1 Liter Bottle Label