FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Canadian Distribution Channel
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:36

Label at a glance#

ProductHand Sanitizer Gel
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) (70%, 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 70% 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

100 mL NDC: 76984-434-01

76984-434-01 100 ml76984-434-01 100 ml

500 ml NDC 76984-434-02

76984-434-02 500 ml76984-434-02 500 ml

1.89L NDC76984-434-03

76984-434-03 1890 ml76984-434-03 1890 ml

2L NDC 76984-434-04

2L NDC 76984-434-042L NDC 76984-434-04

3.79L NDC 76984-434-05

3.79L NDC 76984-434-053.79L NDC 76984-434-05

300ml NDC 76984-434-06300ml NDC 76984-434-06

60ml NDC 76984-434-07

60ml NDC 76984-434-0760ml NDC 76984-434-07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76984-434-012022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-022022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-032022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-042022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-052022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-062022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel
76984-434-072022-01-28C16284748780-1d6a99b39-bf9b-a426-e053-dadaa90af4c2CDC70HSG - Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76984-434-01Hand Sanitizer Gel100 mL in 1 BOTTLE, PLASTICGEL1001
76984-434-02Hand Sanitizer Gel500 mL in 1 BOTTLE, PLASTICGEL5001
76984-434-03Hand Sanitizer Gel1890 mL in 1 BOTTLE, PLASTICGEL18901
76984-434-04Hand Sanitizer Gel2000 mL in 1 BOTTLE, PLASTICGEL20001
76984-434-05Hand Sanitizer Gel3790 mL in 1 BOTTLE, PLASTICGEL37901
76984-434-06Hand Sanitizer Gel300 mL in 1 BOTTLE, PLASTICGEL3001
76984-434-07Hand Sanitizer Gel60 mL in 1 BOTTLE, PLASTICGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76984-434HAND SANITIZER GEL (ALCOHOL) GEL [CANADIAN DISTRIBUTION CHANNEL]1Legacy NDC, 7 package rows20200505_a4d4ca49-570f-79dd-e053-2995a90ac2e4.zip

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
76984-43476984-434-06, 76984-434-01, 76984-434-02, 76984-434-03, 76984-434-04, 76984-434-05, 76984-434-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

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
a4d4d27e-af6a-2212-e053-2995a90a3e4fa4d4ca49-570f-79dd-e053-2995a90ac2e42020-05-04WarningsExact identifier
spl id: a4d4d27e-af6a-2212-e053-2995a90a3e4f
spl set id: a4d4ca49-570f-79dd-e053-2995a90ac2e4

Reported adverse events (FAERS/openFDA)#

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