FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
FRSH HANDS LLC
Effective date
2020-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:20

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v.

OTC - PURPOSE SECTION

Antiseptic

INSTRUCTIONS FOR USE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • on 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.

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.

INSTRUCTIONS FOR USE 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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

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.

INDICATIONS & USAGE SECTION

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

Warnings

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59.15 mL NDC: 78217-001-01

59 mL label59 mL label

118.29 mL NDC: 78217-001-02

118 mL label118 mL label

3785 mL NDC: 78217-001-03

1 gallon label1 gallon label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN1
1047755ethanol 0.75 ML/ML Topical SolutionSCD1
1047755ethanol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78217-001-012022-01-28C16284748780-1d6a99b39-90ee-a426-e053-dadaa90af4c2a771f947-7398-e0cc-e053-2995a90a640c
78217-001-022022-01-28C16284748780-1d6a99b39-90ee-a426-e053-dadaa90af4c2a771f947-7398-e0cc-e053-2995a90a640c
78217-001-032022-01-28C16284748780-1d6a99b39-90ee-a426-e053-dadaa90af4c2a771f947-7398-e0cc-e053-2995a90a640c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78217-001-01Hand Sanitizer59.15 mL in 1 BOTTLE, SPRAYLIQUID59.151
78217-001-02Hand Sanitizer118.294 mL in 1 BOTTLE, SPRAYLIQUID118.2941
78217-001-03Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78217-001HAND SANITIZER (ETHYL ALCOHOL) LIQUID [FRSH HANDS LLC]1Legacy NDC, 3 package rows20200715_a771f947-7398-e0cc-e053-2995a90a640c.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
78217-00178217-001-01, 78217-001-02, 78217-001-03
77808-001

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
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
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
a771f947-7399-e0cc-e053-2995a90a640ca771f947-7398-e0cc-e053-2995a90a640c2020-06-10WarningsExact identifier
spl id: a771f947-7399-e0cc-e053-2995a90a640c
spl set id: a771f947-7398-e0cc-e053-2995a90a640c

Reported adverse events (FAERS/openFDA)#

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