FDA.reportPublic FDA data

Novo ProSeries Foaming Instant Hand Sanitizer

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 Instant Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.1% w/w

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • To help reduce bacteria on the skin that can potentially cause disease.
  • Recommended for repeated use.

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

  • Pump sufficient amount of foam into palm of hand.
  • Wet all surfaces of both hands thoroughly with product, including area under the finger nails and rub until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Cetrimonium Chloride, Lautrimonium Chloride, Phenoxyethanol, Stearalkonium Chloride, Water.

SPL UNCLASSIFIED SECTION

Distributed by:

Noble Chemical, Inc.

2205 Old Philadelphia Pike

Lancaster, PA 17602

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

novo ProSeries

Foaming Instant Hand Sanitizer

Benzalkonium chloride 0.1%

alcohol free

1000 mL (33.8 FL. OZ.)

81551-075 Rev81551-075 Rev

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81551-07581551-075-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARALKONIUM CHLORIDE0OUO26BB88IACT
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-7b0c-baa4-e053-2995a90a143ac0fa897a-292a-5631-e053-2a95a90a58312023-01-02WarningsExact identifier
spl id: f2794ede-7b0c-baa4-e053-2995a90a143a
spl set id: c0fa897a-292a-5631-e053-2a95a90a5831

Reported adverse events (FAERS/openFDA)#

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