70% ALCOHOL HAND SANITIZER- alcohol soap

70% Alcohol Hand Sanitizer by

Drug Labeling and Warnings

70% Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-074
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/27/2018

Labeler - Kutol Products Company, Inc. (004236139)

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