HK Foaming Antibacterial Hand Cleanser

Foaming Antibacterial Hand Cleanser by

Drug Labeling and Warnings

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]

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.

----------

HK Foaming Antibacterial Hand Cleanser

Benzalkonium chloride 0.13% 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.

Directions

Wet hand and forearms.

Apply 5 mL or palmful to hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

Water, lauramine oxide, cetyl trimethyl ammonium chloride, lauryl lactyl lactate, polyoxyethelene (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 hand and forearms.

Apply 5 mL or palmful to hands and forearms.

Scrub thoroughly for at least 15 seconds.

Rinse completely and dry.

FOAMING ANTIBACTERIAL HAND CLEANSER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68604-041
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-7 GLYCERYL COCOATE (UNII: VNX7251543)
LAURYL LACTYL LACTATE, L- (UNII: 26WJR58JDN)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68604-041-02	4 in 1 BOX	03/23/2022
1	NDC: 68604-041-01	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(68604-041)

Revised: 12/2022

Document Id: f10cda41-ad3a-1cca-e053-2a95a90a60e0

34390-5

Set id: dae76497-09b8-2eb0-e053-2a95a90a2d7d

Version: 2

Effective Time: 20221230