FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Essco
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:13

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

DVC Hand Sanitizer

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) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

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

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry. Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

DVC Hand Sanitizer Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

78928-001-04
78928-001-04
78928-001-08
78928-001-08
78928-001-16
78928-001-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78928-001-042022-01-28C16284748780-1d6a99b39-8e81-a426-e053-dadaa90af4c2dc2b6de6-04ed-4009-9033-7d4b62d3aa1e
78928-001-082022-01-28C16284748780-1d6a99b39-8e81-a426-e053-dadaa90af4c2dc2b6de6-04ed-4009-9033-7d4b62d3aa1e
78928-001-162022-01-28C16284748780-1d6a99b39-8e81-a426-e053-dadaa90af4c2dc2b6de6-04ed-4009-9033-7d4b62d3aa1e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78928-001-04Hand Sanitizer118 mL in 1 BOTTLE, PLASTICSOLUTION1181
78928-001-08Hand Sanitizer237 mL in 1 BOTTLE, PLASTICSOLUTION2371
78928-001-16Hand Sanitizer473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78928-001HAND SANITIZER (ALCOHOL) SOLUTION [ESSCO]1Legacy NDC, 3 package rows20200618_dc2b6de6-04ed-4009-9033-7d4b62d3aa1e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78928-00178928-001-04, 78928-001-08, 78928-001-16
72553-005

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
42b8f933-d37f-4ebc-be97-b5fcd2f2f9a8dc2b6de6-04ed-4009-9033-7d4b62d3aa1e2020-06-08WarningsExact identifier
spl id: 42b8f933-d37f-4ebc-be97-b5fcd2f2f9a8
spl set id: dc2b6de6-04ed-4009-9033-7d4b62d3aa1e

Reported adverse events (FAERS/openFDA)#

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