ACUTE-KARE HEALTHCARE PERSONNEL HANDWASH- chloroxylenol soap

Acute-Kare by

Drug Labeling and Warnings

Acute-Kare by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., STERIS Corporation . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Chloroxylenol 1.0%

Purpose

Antiseptic

Uses

• Antiseptic Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

Warnings

For external use only

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Stop use and ask a doctor if irritation and redness develop and symptoms persist for more than 3 days.

Keep out of reach of children In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• wet skin and spread a small amount on the hands
• wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts

Inactive ingredients

Aqua (Water), Propylene Glycol, Sodium Lauroyl Sarcosinate, PEG-150 Distearate, Disodium Cocoamphodiacetate, Polyquaternium-7, Tetrasodium EDTA, Acrylates/PEG-10 Maleate/Styrene Copolymer, Citric Acid, Parfum (Fragrance).

Questions or comments?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 444 ml Bottle Label

Acute
Kare®

deb med®

NDC: 11084-800-13

REORDER #
1206-R2

Hand Soap
Antimicrobial Handwash

Antimicrobial

Moisturizing

Mild Fragrance

Net Contents: 444 ml (15 fl oz)

Manufactured for: Deb USA, Inc.
Charlotte, NC 28217 1-866-783-0422
www.debmed.com

1206-14ESD(F)(218)
61720

INGREDIENTS AND APPEARANCE

ACUTE-KARE   HEALTHCARE PERSONNEL HANDWASH
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	1 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
1	NDC: 11084-800-13	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
2	NDC: 11084-800-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2018

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Corporation		139424188	MANUFACTURE(11084-800)