Drug Facts

Active ingredient

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Use

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

For external use only

When using this product

Avoid contact with the eyes. In case of eye contact, flush with water.

Stop use

if irritation or redness developes. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

If swallowed, seek immediate medical attention or call a poison control center.

Directions

Wet hands, apply soap, rub hands togetehr vigorously for at least 20 seconds.

Rinse and dry hands thoroughly.

Inactive ingredients

Water (Aqua), Lauramine Oxide, Lauryl Betaine, Glycerin, Laurtrimonium Chloride, Sodium PCA, Tocopheryl Acetate, Oleth-10, Tetrasodium EDTA, Citric Acid, Red 40, Yellow 6, Fragrance

GP PBU ANTIMICROBIAL FOAM
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54622-313
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
LAURYL BETAINE (UNII: Y4P927Q133)
GLYCERIN (UNII: PDC6A3C0OX)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
OLETH-10 (UNII: JD797EF70J)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54622-313-01	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	08/05/2021

Labeler - Georgia Pacific Consumer Products (806142217)

Registrant - Cyan Labs S.A. de C.V. (812754130)

Name	Address	ID/FEI	Business Operations
Establishment
Cyan Labs S.A. de C.V.		812754130	manufacture(54622-313) , analysis(54622-313) , label(54622-313) , pack(54622-313)

54622-313