Search by Drug Name or NDC

NDC 54622-0313-01 GP PBU Antimicrobial Foam 0.13 g/100mL Details

GP PBU Antimicrobial Foam 0.13 g/100mL

GP PBU Antimicrobial Foam is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Georgia Pacific Consumer Products. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	54622-0313
Product ID	54622-313_c8d09207-d153-5abc-e053-2a95a90aaf92
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GP PBU Antimicrobial Foam
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Georgia Pacific Consumer Products
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54622-0313-01 (54622031301)

Pricing Information	N/A
NDC Package Code	54622-313-01
Billing NDC	54622031301
Package	1200 mL in 1 BOTTLE, DISPENSING (54622-313-01)
Marketing Start Date	2021-08-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8d09207-d152-5abc-e053-2a95a90aaf92 Details

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLETH-10 (UNII: JD797EF70J)

#	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 not final	part333E	08/05/2021

Labeler - Georgia Pacific Consumer Products (806142217)

Revised: 8/2021

Document Id: c8d09207-d153-5abc-e053-2a95a90aaf92

Set id: c8d09207-d152-5abc-e053-2a95a90aaf92

Version: 1

Effective Time: 20210805