NOVO PROSERIES FOAMING SANITIZING- benzalkonium chloride liquid

Novo ProSeries Foaming Sanitizing by

Drug Labeling and Warnings

Novo ProSeries Foaming Sanitizing by is a Otc medication manufactured, distributed, or labeled by Noble Chemical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzalkonium chloride 0.13% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

To help reduce bacteria on the skin that potentially can cause disease.

WARNINGS

Warnings

For external use only.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop 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.

DOSAGE & ADMINISTRATION

Directions

• Dispense golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds.
• Rinse with water and towel dry.

INACTIVE INGREDIENT

Inactive ingredients

Water, Alcohol, Decyl Glucoside, Phenoxyethanol, Cocamidopropyl PG-dimonium Chloride Phosphate, Polyquatemium 11, Cetrimonium Chloride, Polyquatemium 10, Chlorhexidine Gluconate, Isopropyl Alcohol.

SPL UNCLASSIFIED SECTION

Distributed by:

Noble Chemical, Inc.

2205 Old Philadelphia Pike

Lancaster, PA 17602

PRINCIPAL DISPLAY PANEL

novo ProSeries

Foaming Sanitizing Hand Soap

Benzalkonium Chloride 0.13%

E2 dye & fragrance free

1000 mL (33.8 FL. OZ.)

INGREDIENTS AND APPEARANCE

NOVO PROSERIES FOAMING SANITIZING 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81551-064
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
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81551-064-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	04/27/2021	02/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/27/2021	02/17/2024

Labeler - Noble Chemical (170348663)