SOFT CARE ANTISEPTIC SKIN CLEANSER II- triclosan liquid

Soft Care Antiseptic Skin Cleanser II by

Drug Labeling and Warnings

Soft Care Antiseptic Skin Cleanser II by is a Otc medication manufactured, distributed, or labeled by Diversey, Inc., Kutol Products Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Triclosan 0.55%

PURPOSE

Purpose

Antiseptic handwash

INDICATIONS & USAGE

Uses

For hand washing to decrease bacteria on skin.

WARNINGS

Warnings

For external use only. Do not ingest.

When using this product

Do not use in the eyes.

In case of contact, immediately flush with water.

Stop use and ask a doctor if

irritation and redness develops.

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.

DOSAGE & ADMINISTRATION

Directions

To decrease bacteria on skin.

Use 5 mL (sufficient amount to cover hands with product) and lather in hands with water for at least 30 seconds.

Rinse well with potable water.

Avoid contamination of food during use and storage.

INACTIVE INGREDIENT

Inactive ingredients

Water, Ammonium lauryl sulfate, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, Disodium cocamido MIPA-sulfosuccinate, BHT, Styrene/acrylates copolymer, Glycerin, DMDM hydantoin, Tetrasodium EDTA, Citric acid, Fragrance

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

Sealed Air

Diversey Care

Diversey

H3

Soft Care

Antiseptic Skin

Cleanser II

NDC: 64536-7090-1

Triclosan lotion

DIN 02417324

Product of U.S.A.

Net Contents

1 L/1.06 U.S. Qt.

5982875

REFERENCES

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS # MS0301401

FOR COMMERCIAL AND INDUSTRIAL USE ONLY

See Carton for Lot Code and Expiry Date.

INGREDIENTS AND APPEARANCE

SOFT CARE ANTISEPTIC SKIN CLEANSER II 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64536-7090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.55 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64536-7090-4	600 mL in 1 BOTTLE
2	NDC: 64536-7090-1	1000 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2014

Labeler - Diversey, Inc. (018240817)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company Inc		004236139	manufacture(64536-7090)