SOFT CARE DEFEND FOAM ANTIBACTERIAL HANDWASH- chloroxylenol solution

Soft Care Defend Foam Antibacterial Handwash by

Drug Labeling and Warnings

Soft Care Defend Foam Antibacterial Handwash by is a Otc medication manufactured, distributed, or labeled by Diversey, Inc., Diversey Canada, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol 1.0%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For handwashing to decrease bacteria on the skin.

For occasional use.

WARNINGS

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not ingest.

Do not use in the eyes.

When using this product do not get into eyes.

In case of eye 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

Wet hands and forearms.

Apply 0.4 mL or 1.0 mL of soap to hands.

Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water.

Supervise children when they use this product.

REFERENCES

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301548

FOR COMMERCIAL USE.

See container for Lot Code and Expiry Date.

Store in a cool dry place.

INACTIVE INGREDIENT

Inactive ingredients

Water, Alcohol Denat, Propylene glycol, Ammonium lauryl sulfate, Ammonium laureth sulfate, Isopropyl alcohol, Tetrasodium EDTA

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

NDC: 64536-8308-3

DIN 02448866

Diversey

SoftCare Defend Foam

Antibacterial Handwash

Chloroxylenol Liquid

For commercial use

NSF

Nonfood Compounds

Program listed E2

Registration # 152964

Net Contents

1.2 L/ 1.27 U.S. Qt.

SKU: 100907902

INGREDIENTS AND APPEARANCE

SOFT CARE DEFEND FOAM ANTIBACTERIAL HANDWASH  
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64536-8308
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)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64536-8308-2	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2016
2	NDC: 64536-8308-3	1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2016

Labeler - Diversey, Inc. (018240817)

Establishment
Name	Address	ID/FEI	Business Operations
Diversey Canada, Inc.		249266974	manufacture(64536-8308)