ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride soap 
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 F215F

Dosage and Administration

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredient Section

Inactive Ingredients Water, Cetrimonium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Lauraminodipropionate, Citric Acid, Fragrance, Disodium EDTA, Methyllisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 33

Indications and Usage Section

Uses Handwash to help decrease bacteria on skin.

Keep Out Of Reach Of Children Section

Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.

Purpose Section

Purpose Antibacterial Handwashing

Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only.

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

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

Principal Display Label

Pricipal Label Display

ANTIBACTERIAL HAND CLEANSER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66608-215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 35 (UNII: 02BXM5Q7GE)  
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
SORBITOL (UNII: 506T60A25R)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
SODIUM LAURIMINODIPROPIONATE (UNII: 7G447D0DH9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66608-215-781000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2017
2NDC:66608-215-65800 mL in 1 BAG; Type 0: Not a Combination Product06/28/2017
3NDC:66608-215-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/28/2017
Labeler - Kimball Midwest (017906231)
Registrant - Kutol Products, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products, Inc.004236139manufacture(66608-215)

Revised: 8/2023
Document Id: 03a8d6f3-00f9-5ae3-e063-6294a90a91c2
Set id: 9ce9489e-39a1-d51c-e053-2995a90a3e5c
Version: 5
Effective Time: 20230824
 
Kimball Midwest