HAND SANITIZER- 62% ethyl alcohol gel 
Kimball Midwest

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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Kimball Midwest F056F

Dosage and Administration

Directions Apply a small amount to palm. Briskly rub, covering hands with product until dry.

Inactive Ingredient Section

Inactive Ingredients Water, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Aminomethylpropanol

Indications and Usage Section

Uses For hand cleaning to decrease bacteria on skin.

Keep Out Of Reach Of Children Section

Keep Out Of Reach Of Children If swallowed, contact a physician or poison center.

Purpose Section

Purpose Antibacterial Agent

Active Ingredient Section

Active Ingredient Ethyl Alcohol 62% v/v

Warnings Section

Warnings

For external use only.

Flammable. Keep away from head or flame.

Do not use in the eyes. In case of contact rinse thoroughly.

Stop and ask a doctor if irritation and redness appears and lasts.

Principal Display Label

Principal Display Label

HAND SANITIZER 
62% ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66608-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 1342 (UNII: 809Y72KV36)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66608-056-35118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/04/2019
Labeler - Kimball Midwest (017906231)
Registrant - Kutol Products, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products, Inc.004236139manufacture(66608-056)

Revised: 8/2023
Document Id: 03a8c5b9-b080-8b10-e063-6294a90ac578
Set id: 9ce6f156-f1a7-32e7-e053-2995a90adb29
Version: 3
Effective Time: 20230824
 
Kimball Midwest