SOFT CARE SENTRY - benzalkonium chloride solution 
Diversey, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

For hands to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Do not ingest

Do not use in the eyes.

When using this product do not get in eyes.

In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation and redness develop.

If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if you are allergic to any ingredients.

Directions

Apply a small amount to hands, add water and lather by rubbing hands together for 20 seconds, rinse with potable water.

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0801277

FOR COMMERCIAL USE

See container for Lot Code and Expiry Date.

Store in a cool dry place.

Inactive ingredients

Water, Cocamidopropyl betaine, Cocamidopropyl PG-Dimmonium Chloride Phosphate, Laurtrimonium Chloride, PEG-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

Questions or comments?

1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

www.diversey.com

Diversey

NDC 64536-1948-3

Soft Care Sentry

Foaming Antibacterial Hand Soap

For commercial use

NSF

Nonfood Compounds

Program Listed E2

Registration 156691

(L)     Exp.

Net Contents

1.3 L / 1.37 U.S. Qt.

SKU: 101100320

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SOFT CARE SENTRY 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64536-1948
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64536-1948-31300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/19/2018
Labeler - Diversey, Inc. (018240817)
Establishment
NameAddressID/FEIBusiness Operations
KUTOL PRODUCTS COMPANY004236139manufacture(64536-1948)

Revised: 3/2018
Document Id: b113e4a1-fdba-4f2a-9800-994b7aa6a924
Set id: f0686b7b-2f41-4656-8eb2-09483571a1bc
Version: 2
Effective Time: 20180301
 
Diversey, Inc.