Foaming Antibacterial Hand Wash by Global Equipment Company / Kutol Products Company / Kutol Product Company Global Equipment F213F

Foaming Antibacterial Hand Wash by

Drug Labeling and Warnings

Foaming Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Global Equipment Company, Kutol Products Company, Kutol Product Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING ANTIBACTERIAL HAND WASH- benzalkonium chloride solution 
Global Equipment Company

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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Global Equipment F213F

Active Ingredient - Benzalkonium Chloride

Purpose - Antibacterial

Uses - For handwashing to decrease bacteria on skin.

Warnings

For external use only. Avoid contact with eyes. If contact occurs, flush with water.

Stop use and ask a doctor if, in rare instances, redness or irritation develop and persists for more than 72 hours.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

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

Inactive Ingredients - Water, Laurtrimonium Chloride, Cocamidopropyl Betaine, PEG-6 Cocamide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Fragrance, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Yellow 5, Red 33.

Primary Label

FOAMING ANTIBACTERIAL HAND WASH 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78641-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78641-213-50	1200 mL in 1 BAG; Type 0: Not a Combination Product	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2020

Labeler - Global Equipment Company (001472216)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Product Company		004236139	manufacture(78641-213)

Revised: 8/2023

Document Id: 03a91ad5-cb3a-beac-e063-6294a90a7976

34390-5

Set id: a7331431-df40-7ff4-e053-2995a90af9e5

Version: 3

Effective Time: 20230824