HAND SANITIZER

Manufacturer
NOVUS TRADING GROUP LLC
Effective date
2020-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:30

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For hand washing in order to sanitize skin with 99.9% efficiency (hands must air dry)

Dosage and administration

Wet hands thoroughly with product and allow to dry without rinse. Children undersiz years of age should be supervised when using this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Sterile distilled water or boiled cold water.
  3. Aloe Vera

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Indications and usage

INDICATIONS & USAGE SECTION

For hand washing in order to sanitize skin with 99.9% efficiency (hands must air dry)

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

Do not use if you are allergic to any of the ingredients.

Discontinue use if irritation or redness develops, and if condition persist for more than 72 hours consult a physician.

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision.

Directions of use

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without rinse.
  • Children undersiz years of age should be supervised when using this product.

Other Information

OTHER SAFETY INFORMATION

Store in a dry place away from fire.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified (RO) Water, Aloe Vera

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 SANITIZING WET WIPES LABEL80 SANITIZING WET WIPES LABEL80 SANITIZING WET WIPES with 75% Ethyl Alcohol, NDC: 80402-001-80

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80402-001-802022-01-28C16284748780-1d6a99b39-9470-a426-e053-dadaa90af4c2ae3b6144-aea8-150a-e053-2a95a90ac65a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80402-001-80HAND SANITIZER4.25 mL in 1 PACKETCLOTH4.251
80402-001-80HAND SANITIZER80 in 1 CANISTERCLOTH801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80402-001HAND SANITIZER (ALCOHOL) CLOTH [NOVUS TRADING GROUP LLC]1Legacy NDC, 2 package rows20200930_ae3b6144-aea8-150a-e053-2a95a90ac65a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80402-00180402-001-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
ae3b0c30-863a-ded2-e053-2995a90aec50ae3b6144-aea8-150a-e053-2a95a90ac65a2020-09-01WarningsExact identifier
spl id: ae3b0c30-863a-ded2-e053-2995a90aec50
spl set id: ae3b6144-aea8-150a-e053-2a95a90ac65a

Reported adverse events (FAERS/openFDA)#

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