Hand Sanitizer

Manufacturer
One Sanitizer, LLC | Brenntag North America Inc
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:08

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

30 mL NDC: 79516-9664-1 30 ml gel30 ml gel

120 mL NDC: 79516-9664-2 4ozvanillasandalwood4ozvanillasandalwood 4ozcoconutlemongrass4ozcoconutlemongrass 4ozlavendermint4ozlavendermint 4ozeucalmint4ozeucalmint 120 ml gel120 ml gel

252 mL NDC: 79516-9664-3 252 mL GEL252 mL GEL

500 mL NDC: 79516-9664-4 500 ml gel500 ml gel

1893 mL NDC: 79516-9664-5 1893 ml gel1893 ml gel

3785 mL NDC: 79516-9664-6 3785 ml gel3785 ml gel

120 mL NDC: 79516-4934-1 120 ml who120 ml who

1,893 mL NDC: 79516-4934-2 1893 ml who1893 ml who

3,785 mL NDC: 79516-4934-3 3785 ml who3785 ml who

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79516-4934-1Hand Sanitizer120 mL in 1 BOTTLE, SPRAYLIQUID1202
79516-4934-2Hand Sanitizer1893 mL in 1 BOTTLE, SPRAYLIQUID18932
79516-4934-3Hand Sanitizer3785 mL in 1 BOTTLE, SPRAYLIQUID37852
79516-9664-1Hand Sanitizer0.03 L in 1 BOTTLE, PLASTICGEL0.032
79516-9664-2Hand Sanitizer0.12 L in 1 BOTTLE, PLASTICGEL0.122
79516-9664-3Hand Sanitizer0.252 L in 1 BOTTLE, PUMPGEL0.2522
79516-9664-4Hand Sanitizer0.5 L in 1 BOTTLE, PUMPGEL0.52
79516-9664-5Hand Sanitizer1.893 L in 1 BOTTLE, PUMPGEL1.8932
79516-9664-6Hand Sanitizer3.785 L in 1 BOTTLE, PUMPGEL3.7852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79516-4934HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (WHO RECOMMENDED HAND RUB) LIQUID [ONE SANITIZER, LLC]2Legacy NDC, 3 package rows20200722_a7aa183f-8437-ff69-e053-2a95a90af0e0.zip
79516-9664HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (WHO RECOMMENDED HAND RUB) LIQUID [ONE SANITIZER, LLC]2Legacy NDC, 6 package rows20200722_a7aa183f-8437-ff69-e053-2a95a90af0e0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
aaf6247d-8271-05ae-e053-2a95a90afbc0a7aa183f-8437-ff69-e053-2a95a90af0e02020-07-21WarningsExact identifier
spl id: aaf6247d-8271-05ae-e053-2a95a90afbc0
spl set id: a7aa183f-8437-ff69-e053-2a95a90af0e0

Reported adverse events (FAERS/openFDA)#

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