FDA.reportPublic FDA data

Novo ProSeries Foaming Sanitizing

Manufacturer
Noble Chemical
Effective date
2023-01-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:39:50

Label at a glance#

ProductNovo ProSeries Foaming Sanitizing
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.13% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

novo ProSeries

Foaming Sanitizing Hand Soap

Benzalkonium Chloride 0.13%

E2 dye & fragrance free

1000 mL (33.8 FL. OZ.)

81551-064 Rev81551-064 Rev

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81551-06481551-064-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2794ede-7b0b-baa4-e053-2995a90a143ac0fa06c0-2741-842e-e053-2995a90a09eb2023-01-02WarningsExact identifier
spl id: f2794ede-7b0b-baa4-e053-2995a90a143a
spl set id: c0fa06c0-2741-842e-e053-2995a90a09eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.