FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SynCardia Systems, LLC
Effective date
2020-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:35:11

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 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.

World Health Organization (WHO) recommended Handrub Formulation

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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. Avoid contact with eyes, ears and mouth.

Keep out of reach of children.

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

Stop use and ask a doctor if irritation or rash occurs.

Do not use

OTC - DO NOT USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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.

Storage

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

distilled water, glycerin, hydrogen peroxide

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.78L NDC: 74681-541-01 SynCardia Hand Sanitizer front LabelSynCardia Hand Sanitizer front Label Hand Sanitizer Back Product LabellHand Sanitizer Back Product Labell

946.353ml NDC: 74681-541-02 Hand Sanitizer Front Product Label 946.353 mlHand Sanitizer Front Product Label 946.353 ml Hand Sanitizer Back Product Label 946.353 mlHand Sanitizer Back Product Label 946.353 ml

118.294ml NDC: 74681-541-04 Hand Sanitizer Single Product Label 118.294mlHand Sanitizer Single Product Label 118.294ml

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
74681-54174681-541-01, 74681-541-02, 74681-541-04

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
a84fe1d3-36f7-3fd6-e053-2995a90aa7d4a2699a2b-6961-54f0-e053-2995a90afe162020-09-30WarningsExact identifier
spl set id: a2699a2b-6961-54f0-e053-2995a90afe16

Reported adverse events (FAERS/openFDA)#

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