NDC Code(s) : 11084-800-41
Packager : SC Johnson Professional USA, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acute-Kare CHLOROXYLENOL SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-800
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:11084-800-411000 mL in 1 BOTTLE TYPE 0: NOT A COMBINATION PRODUCT02/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH DRUG 505G(a)(3) 02/01/2018 12/31/2027

LABELER - SC Johnson Professional USA, Inc.(607378015)

Establishment
Name Address ID/FEI Business Operations
Apex International Mfg LLC 015226132 MANUFACTURE(11084-800)

PRINCIPAL DISPLAY PANEL

SCJ PROFESSIONAL
HEALTHCARE

Acute Kare®

NDC 11084-800-41

Hand Soap
Antimicrobial Handwash

Antimicrobial | Moisturising | Mild Fragrance

1 Liter SDS (33.8 fl oz) (1.05 qt)
SAP # 4000000051

Manufactured for:
SC Johnson Professional USA, Inc.
Charlotte, NC 28217
1-866-783-0422 www.scjp.com
Pat. www.scjp.com/patents

REORDER #
1206-87

deb
SKIN CARE

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label