KE-53PS GEL HAND SANITIZER solution

KE-53PS Gel Hand Sanitizer by

Drug Labeling and Warnings

KE-53PS Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kinzua Environmental, Inc., Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 62% v/v.....Antibacterial Agent

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Carbomer, Tocopheryl Acetate (Vitamin E), Aminomethyl Prpoanol

PURPOSE

For hand cleaning to decrease bacteria on skin.

WARNINGS

For external use only.

Flammable. Keep away from heat or flame.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, contact a physician or poison center. 

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

INDICATIONS & USAGE

For hand cleaning to decrease bacteria on skin.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, contact a physician or poison center.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, contact a physician or poison center.

PRINCIPAL DISPLAY PANEL

  64121-056-35.jpg

INGREDIENTS AND APPEARANCE

KE-53PS GEL HAND SANITIZER 
ke-53ps gel hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64121-056
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)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64121-056-35	119 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/05/2013

Labeler - Kinzua Environmental, Inc. (612966374)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(64121-056) , analysis(64121-056) , pack(64121-056)