SOFT CARE SENTRY- benzalkonium chloride solution

Soft Care Sentry by

Drug Labeling and Warnings

Soft Care Sentry by is a Otc medication manufactured, distributed, or labeled by Diversey, Inc., KUTOL PRODUCTS COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For hands to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

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

REFERENCES

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 INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?

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

www.diversey.com

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SOFT CARE SENTRY 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64536-1948
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64536-1948-3	1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/19/2018

Labeler - Diversey, Inc. (018240817)

Establishment
Name	Address	ID/FEI	Business Operations
KUTOL PRODUCTS COMPANY		004236139	manufacture(64536-1948)