SOFT CARE FOAM INSTANT HAND SANITIZER- alcohol liquid

Soft Care Foam Instant Hand Sanitizer by

Drug Labeling and Warnings

Soft Care Foam Instant Hand Sanitizer 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

Ethyl alcohol 62% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses:

For hands to decrease bacteria on the skin.

Recommended for repeated 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 the eyes.

In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or 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.

DOSAGE & ADMINISTRATION

Directions

Apply 1-2 ml into hands, rub product vigorously over hands covering all surfaces.

Allow to air dry - do not rinse.

REFERENCES

Other information:

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301383

Store below 35 C (95 F)

See container for Lot Code and Expiry Date

Do not contaminate water, food or feed during use, storage or disposal.

For Commercial and Industrial Use Only

INACTIVE INGREDIENT

Inactive ingredients

Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbabensis Leaf Juice, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

NDC: 64536-7295-4

Diversey

SoftCare

Foam Instant

Hand Sanitizer

Kills 99.9% of germs and bacteria

Aloe and Vitamin E to moisturize

Contains alcohol

Clean

Protect

Refresh

Net Contents

532 mL/1.12 U.S. Pt.

SKU: 100930835

INGREDIENTS AND APPEARANCE

SOFT CARE FOAM INSTANT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64536-7295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64536-7295-5	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2016
2	NDC: 64536-7295-4	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2016

Labeler - Diversey, Inc. (018240817)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(64536-7295)