FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
EXCLAVE HOLDINGS INC. | JOHN SALSMAN
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:21

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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) (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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

189 mL NDC: 78461-0000-4

4oz label4oz label

147 mL NDC: 78461-0000-5

5oz label5oz label

236 mL NDC: 78461-0000-8

8oz label8oz label

946 mL NDC: 78461-0000-2

32oz label32oz label

3785 mL NDC: 78461-0000-1

1gal label1gal label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78461-0000-12022-01-28C16284748780-1d6a99b39-73cd-a426-e053-dadaa90af4c2HAND SANITIZER
78461-0000-22022-01-28C16284748780-1d6a99b39-73cd-a426-e053-dadaa90af4c2HAND SANITIZER
78461-0000-42022-01-28C16284748780-1d6a99b39-73cd-a426-e053-dadaa90af4c2HAND SANITIZER
78461-0000-52022-01-28C16284748780-1d6a99b39-73cd-a426-e053-dadaa90af4c2HAND SANITIZER
78461-0000-82022-01-28C16284748780-1d6a99b39-73cd-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78461-0000-1Hand Sanitizer3785 mL in 1 BOTTLESPRAY37851
78461-0000-2Hand Sanitizer946 mL in 1 BOTTLESPRAY9461
78461-0000-4Hand Sanitizer118 mL in 1 BOTTLESPRAY1181
78461-0000-5Hand Sanitizer147 mL in 1 BOTTLESPRAY1471
78461-0000-8Hand Sanitizer236 mL in 1 BOTTLESPRAY2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78461-0000HAND SANITIZER (ALCOHOL) SPRAY [EXCLAVE HOLDINGS INC.]1Legacy NDC, 5 package rows20200607_a68e617a-2509-a2f3-e053-2a95a90a3dbf.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
78461-000078461-0000-4, 78461-0000-5, 78461-0000-8, 78461-0000-2, 78461-0000-1

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a68e528a-0d89-1580-e053-2995a90aec76a68e617a-2509-a2f3-e053-2a95a90a3dbf2020-05-26WarningsExact identifier
spl id: a68e528a-0d89-1580-e053-2995a90aec76
spl set id: a68e617a-2509-a2f3-e053-2a95a90a3dbf

Reported adverse events (FAERS/openFDA)#

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