Hand-Gel Antibacterial Soap

Han Gel Antibacterial by

Drug Labeling and Warnings

Han Gel Antibacterial by is a Otc medication manufactured, distributed, or labeled by Auto-Chlor System. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAN GEL ANTIBACTERIAL- 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-Gel Antibacterial Soap

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 occures, rinse eyes thoroughly with water.

Directions

Wet hands and forearms.

Apply 5 mL or palmful to hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

water, ethoxylated ester, lauramine oxide, _cetyl trimethyl ammonium chloride, _lauryl lactyl tactate, polyoxyethylene (7) glyceryl monococoate, DMDM hydantoin,Disodium ethylenediamine tetraacetate, fragrance, 2-propen-1 aminium, N,N-dimethyl-N-2-propenyl-, chloride, polymer with 2-propenamide, dye, dye

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

Directions

Wet hands and forearms

Apply 5mL or palmful to hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

ACL10242 HK Han-Gel Antibacterial Soap 1 Gal 064.22

HAN GEL ANTIBACTERIAL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68604-242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LAURYL LACTYL LACTATE, DL- (UNII: M96FF85L6Z)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68604-242-02	4 in 1 BOX	03/03/2022	03/23/2022
1	NDC: 68604-242-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/03/2022	03/23/2022

Labeler - Auto-Chlor System (965194330)

Establishment
Name	Address	ID/FEI	Business Operations
Auto-Chlor System		965194330	manufacture(68604-242)

Revised: 3/2022

Document Id: dae52abf-07fc-6c7a-e053-2a95a90a747c

34390-5

Set id: d9416c7f-8327-4751-e053-2995a90a17be

Version: 2

Effective Time: 20220323