Hand Kleen Foaming Antibacterial Hand Cleanser

Hand Kleen Foaming Antibacterial Hand Cleanser by

Drug Labeling and Warnings

Hand Kleen Foaming Antibacterial Hand Cleanser by is a Otc medication manufactured, distributed, or labeled by Auto-Chlor System. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND KLEEN FOAMING ANTIBACTERIAL HAND CLEANSER- benzalkonium chloride liquid 
Auto-Chlor System

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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Hand Kleen Foaming Antibacterial Hand Cleanser

Benzalkonium chloride 0.26% w/w

Antiseptic handwash

For handwashing to decrease bacteria on the skin.

For external use only.

When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Wet hands and forearms.

Apply 5mL or palmful to hand and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

Water, laurmine oxide, _cetyl trimethyl ammonium chloride, _lauryl lactyl lactate, polyoxyethelene (7) glyceryl monococoate, DMDM hydantoin, Disodium ethylenediamine tetraacetate, frangrance, 2-propen-1 aminium, N,N-dimethyl-N-2-propenyl-, chloride polymer with 2-propenamide

Directions

Wet hands and forearms.

Apply 5 mL or palmful to hand and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center righ away.

ACL30241 HK Foaming Antibacterial Hand Cleanser 1000ml Label 355.21

ACL30241 HK Foaming Antibacterial Hand Cleanser 1000ml Label 355.21.jpgACL30241 HK Foaming Antibacterial Hand Cleanser 1000ml Label 355.21.jpg

HAND KLEEN FOAMING ANTIBACTERIAL HAND CLEANSER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68604-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE26 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
LAURYL LACTYL LACTATE, DL- (UNII: M96FF85L6Z)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68604-241-024 in 1 BOX01/07/2022
1NDC: 68604-241-011000 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/07/202212/30/2022
Labeler - Auto-Chlor System (965194330)
Establishment
NameAddressID/FEIBusiness Operations
Auto-Chlor System965194330manufacture(68604-241)

Revised: 12/2022
Document Id: f10d1b37-a870-7739-e053-2a95a90a31de
Set id: d4c4a324-0a9a-b602-e053-2a95a90afe69
Version: 3
Effective Time: 20221230
 
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