PACIFIC BLUE ULTRA- benzalkonium chloride soap

Pacific Blue Ultra by

Drug Labeling and Warnings

Pacific Blue Ultra by is a Otc medication manufactured, distributed, or labeled by Georgia Pacific Consumer Products, Vi-Jon, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13% w/w

Purpose

Antiseptic

Uses

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

For external use only

WHEN USING

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

STOP USE

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

Keep our of reach of children.

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

Directions

Wet hands, apply soap, rub hand together vigorously for at least 20 seconds.  Rinse and dry hand thoroughly with a disposable paper towel.

Inactive ingredients

Water, Glycerin, Lauramine Oxide, Cocamidopropyl Betaine, PEG-150 Distearate, Aloe Barbadensis Leaf Juice, Cocamide MEA, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin

Additional rear label text for manual dispensers

Pacific Blue Ultra

Antimicrobial Foam Soap

Fragrance Free

SKU 43818

Manufactured for Georgia-Pacific Consumer Products LP. Atlanta, GA 30303

Quesitons? Call 1-866-HELLOGP (435-5647)

or visit us online at www.gppro.com

(c) Georgia Pacific Consumer Products LP.  All rights reserved.

43818-1 PRDRevA16 L0015809BA

Additional rear label text for automatic dispensers

Pacific Blue Ultra

automated Antimicrobial Foam Soap

Fragrance Free

SKU 43822

Manufactured for Georgia-Pacific Consumer Products LP. Atlanta, GA 30303

Quesitons? Call 1-866-HELLOGP (435-5647)

or visit us online at www.gppro.com

(c) Georgia Pacific Consumer Products LP.  All rights reserved.

43822-V1 PRDRevA L0017076BA

principal display panel

Antimicrobial Foam Soap

1200 mL (40.5 FL OZ)

572.000/572AB

INGREDIENTS AND APPEARANCE

PACIFIC BLUE ULTRA 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54622-572
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54622-572-01	1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2016

Labeler - Georgia Pacific Consumer Products (806142217)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		790752542	manufacture(54622-572)