HYGENIX AF GEL- benzalkonium chloride gel

Hygenix AF Gel by

Drug Labeling and Warnings

Hygenix AF Gel by is a Otc medication manufactured, distributed, or labeled by GM Industrial, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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Drug Facts

Benzalkonium chloride 0.1%

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

Directions

• Pump a small amount of gel into pal of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together briskly until dry.

Water, carbomer, glycerin, lactic acid.

PRINCIPAL DISPLAY PANEL

74146-244-02

INGREDIENTS AND APPEARANCE

HYGENIX AF GEL 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74146-244
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74146-244-03	24 in 1 BOX	10/05/2021
1	NDC: 74146-244-02	200 mL in 1 CONTAINER; 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	10/05/2021

Labeler - GM Industrial, Inc. (025827197)

Establishment
Name	Address	ID/FEI	Business Operations
GM Industrial, Inc.		025827197	manufacture(74146-244) , pack(74146-244) , label(74146-244) , repack(74146-244) , relabel(74146-244)