Kindest Kare Advanced Antimicrobial Handwash (Benzalkonium Chloride) Liquid [Deb Usa, Inc.] -

KINDEST KARE ADVANCED ANTIMICROBIAL HANDWASH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]
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NDC	11084-806-13, 11084-806-41
Set ID	c6301bb7-f1f3-4e34-97b6-e57e66eddec2
Category	HUMAN OTC DRUG LABEL
Packager	SC Johnson Professional USA, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333E

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Benzalkonium Chloride 0.7%
Purpose

Antiseptic
Uses

Healthcare Personnel 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; 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 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 hands and apply a small amount of product. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.
Inactive ingredients

Aqua (Water), Hexylene Glycol, Cocamidopropylamine Oxide, PEG- 80 Sorbitan Laurate, Hydroxypropyl Methylcellulose, PEG-150 Distearate, PEG-8 Dimethicone, Sorbitol, Glycerin, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamide MIPA, Soyamidopropylamine Oxide, Lauramine Oxide, Phenoxyethanol, Potassium Hydroxide, Citric Acid
Questions or comments?

1-866-783-0422
PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

SCJ PROFESSIONAL
HEALTHCARE

Kindest Kare®

NDC 11084-806-41

Hand Soap
Antimicrobial Handwash
Advanced

Health Personnel Handwash

Moisturising

Fragrance Free

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

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

REORDER #
6267-87

deb
SKIN CARE

SAP # 4000000170

INGREDIENTS AND APPEARANCE

KINDEST KARE ADVANCED ANTIMICROBIAL HANDWASH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-806
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.7 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-806-41	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018
2	NDC:11084-806-13	444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018	06/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	02/01/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
STERIS Corporation		139424188	MANUFACTURE(11084-806)

Name	Address	ID/FEI	Business Operations
Establishment
APEX International, Inc.		015226132	MANUFACTURE(11084-806)

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Medic

KINDEST KARE ADVANCED ANTIMICROBIAL HANDWASH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]

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