PACIFIC BLUE ULTRA ANTIMICROBIAL FOAM FRAGRANCE FREE- benzalkonium chloride solution

Pacific Blue ultra Antimicrobial Foam Fragrance Free by

Drug Labeling and Warnings

Pacific Blue ultra Antimicrobial Foam Fragrance Free by is a Otc medication manufactured, distributed, or labeled by Georgia-Pacific Consumer Products, CYAN Labs S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride, 0.13% w/w

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

Stop use

if irritation or redness develops. 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 together vigorously for at least 20 seconds.

Rinse and dry hands thoroughly with a disposable paper towel.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PACIFIC BLUE ULTRA ANTIMICROBIAL FOAM FRAGRANCE FREE 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54622-316
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
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
OLETH-10 (UNII: JD797EF70J)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL BETAINE (UNII: Y4P927Q133)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM PIDOLATE (UNII: 1V74VH163T)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54622-316-01	4 in 1 BOX	06/14/2023
1		1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 54622-316-02	3 in 1 BOX	06/14/2023
2		1200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/14/2023

Labeler - Georgia-Pacific Consumer Products (806142217)

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

Establishment
Name	Address	ID/FEI	Business Operations
Cyan Labs S.A. de C.V.		812754130	manufacture(54622-316) , analysis(54622-316) , label(54622-316) , pack(54622-316)