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KE-53PS Gel Hand Sanitizer

Dosage form: solution
Ingredients: ALCOHOL 62mL in 100mL
Labeler: Kinzua Environmental, Inc.
NDC Code: 64121-056

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.

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.

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KE-53PS GEL HAND SANITIZER 
ke-53ps gel hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64121-056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYACRYLIC ACID (250000 MW) 
GLYCERIN 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
AMINOMETHYLPROPANOL 
ALOE VERA LEAF 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
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/FEIOperations
Kutol Products Company, Inc.004236139manufacture(64121-056), analysis(64121-056), pack(64121-056)

Revised: 01/2014
 
Kinzua Environmental, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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