Han-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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Han-Gel Antibacterial Soap

Benzalkonium chloride w/w

Antiseptic handwash

For handwashing to decrease bacteria on the skin

For external use only.

When using this product, do not get into the eyes. If contact occurs, 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 lactate, 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

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 5 mL or palmful to hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

HAN GEL ANTIBACTERIAL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68604-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LAURYL LACTYL LACTATE, L- (UNII: 26WJR58JDN)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68604-042-02	4 in 1 BOX	03/23/2022
1	NDC: 68604-042-01	1000 mL in 1 BAG; 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	03/23/2022	12/30/2022

Labeler - Auto-Chlor System (965194330)

Establishment
Name	Address	ID/FEI	Business Operations
Auto-Chlor System		965194330	manufacture(68604-042)

Revised: 12/2022

Document Id: f10cebc2-557d-673a-e053-2a95a90a2ef8

34390-5

Set id: dae551e0-f0c9-a1e3-e053-2a95a90a9e59

Version: 2

Effective Time: 20221230