SOFT CARE INSTANT HAND SANITIZER AF- benzalkonium chloride solution

Soft Care Instant Hand Sanitizer AF by

Drug Labeling and Warnings

Soft Care Instant Hand Sanitizer AF 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 into the 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 0.4-1 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 MS0881162

FOR COMMERCIAL USE

See container for Lot Code and Expiry Date.

Store in a cool dry place.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Cocamidopropyl betaine, Propylene glycol, Phenoxyethanol, PEG-7 Glyceryl cocoate, Fragrance, Tetrasodium EDTA, Aloe barbadensis leaf juice, Tocopheryl acetate

QUESTIONS

Questions or comments?

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

www.sealedair.com

PRINCIPAL DISPLAY PANEL

NDC: 64536-3628-3

Diversey

SoftCare

Instant Hand

Sanitizer AF

Alcohol-Free Foam Hand Sanitizer

(L) Exp.

NSF

Nonfood Compounds

Program Listed E3

Registration # 156292

Net Contents

1.3 L/ 1.37 U.S. Qt,

SKU: 100961733

INGREDIENTS AND APPEARANCE

SOFT CARE INSTANT HAND SANITIZER AF 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64536-3628
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64536-3628-3	1300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/14/2017

Labeler - Diversey, Inc. (018240817)

Establishment
Name	Address	ID/FEI	Business Operations
KUTOL PRODUCTS COMPANY		004236139	manufacture(64536-3628)