KE-53PS GEL HAND SANITIZER- ke-53ps gel hand sanitizer solution 
Kinzua Environmental, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KE-53PS Gel Hand Sanitizer

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

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

For hand cleaning to decrease bacteria on skin.

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. 

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

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. If swallowed, contact a physician or poison center.

64121-056-35.jpg  64121-056-35.jpg

KE-53PS GEL HAND SANITIZER 
ke-53ps gel hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64121-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64121-056-35119 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/05/2013
Labeler - Kinzua Environmental, Inc. (612966374)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(64121-056) , analysis(64121-056) , pack(64121-056)

Revised: 1/2014
Document Id: 7cf2c895-73ad-498d-a7ef-40d2fae7ca20
Set id: b2ed523d-ab34-434f-aed0-d0ec58d9f873
Version: 1
Effective Time: 20140117
 
Kinzua Environmental, Inc.