FDA.reportPublic FDA data

Novalent Shield Advanced Antiseptic Hand Sanitizer

Manufacturer
IndusCo, Ltd. (dba) Novalent Biotech
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:17

Label at a glance#

ProductNovalent Shield Advanced Antiseptic Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

Hand Sanitizer to help decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Apply a small amount into palms of hands and spread on both hands. Rub into skin until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antispetic Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

in ears or mouth and avoid mucus membranes.

When using this product.

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.
  • In case of contact flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children should be supervised when using this product.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount into palms of hands and spread on both hands.
  • Rub into skin until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, 3-(Trimethoxy) Propyl Dimethyl Octadecyl Ammonium Chloride, ethoxylated alcohol, Citrus Limon (Lemon) Fruit Oil.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90020-00090020-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
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
2cd86be7-98d9-ceb7-e063-6294a90a85bfac11f425-1547-125f-e053-2995a90a595c2025-01-29WarningsExact identifier
spl set id: ac11f425-1547-125f-e053-2995a90a595c

Reported adverse events (FAERS/openFDA)#

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