70% Alcohol Hand Sanitizer (Alcohol) Soap [Kutol Products Company, Inc.] -

70% ALCOHOL HAND SANITIZER (ALCOHOL) SOAP [KUTOL PRODUCTS COMPANY, INC.]
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ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v.....Antibacterial Agent
INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Triisopropanolamine
PURPOSE

For handwashing to help reduce bacteria on the skin
WARNINGS

For external use only.

Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.
DOSAGE & ADMINISTRATION

Apply to hair or body. Work into a rich lather. Massage hair and body completely for at least 30 seconds. Rinse thoroughly. Dry completely.
INDICATIONS & USAGE

For handwashing to help reduce bacteria on the skin.

Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison control center.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

70% ALCOHOL HAND SANITIZER
alcohol soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.07 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50865-074-41	6 in 1 PACKET	02/27/2018
1		1000 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:50865-074-44	4 in 1 PACKET	02/27/2018
2		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/27/2018

Labeler - Kutol Products Company, Inc. (004236139)

Name	Address	ID/FEI	Business Operations
Establishment
Kutol Products Company, Inc.		004236139	manufacture(50865-074) , analysis(50865-074) , label(50865-074) , pack(50865-074)

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