FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
FRSH HANDS LLC
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:25

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

  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. Glycerin (1.45% v/v).
  3. Carbopol 940.
  4. Triethanolamine
  5. Essential Oil
  6. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl 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

Distilled Water, Carbopol 940, Glycerin, Triethanolamine, Essential Oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59.147 mL NDC: 78217-002-01

59 mL label59 mL label

118.294 mL NDC: 78217-002-02

118 mL Label118 mL Label

236.59 mL NDC: 78217-002-03

236 mL Label236 mL Label

473.176 mL NDC: 78217-002-04

473 mL Label473 mL Label

3785 mL NDC: 78217-002-05

3.78 L Label3.78 L Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78217-002-012022-01-28C16284748780-1d6a99b39-c400-a426-e053-dadaa90af4c2aa6c2478-b3b3-a3aa-e053-2a95a90aa83e
78217-002-022022-01-28C16284748780-1d6a99b39-c400-a426-e053-dadaa90af4c2aa6c2478-b3b3-a3aa-e053-2a95a90aa83e
78217-002-032022-01-28C16284748780-1d6a99b39-c400-a426-e053-dadaa90af4c2aa6c2478-b3b3-a3aa-e053-2a95a90aa83e
78217-002-042022-01-28C16284748780-1d6a99b39-c400-a426-e053-dadaa90af4c2aa6c2478-b3b3-a3aa-e053-2a95a90aa83e
78217-002-052022-01-28C16284748780-1d6a99b39-c400-a426-e053-dadaa90af4c2aa6c2478-b3b3-a3aa-e053-2a95a90aa83e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78217-002-01Hand Sanitizer59.147 mL in 1 BOTTLE, PLASTICGEL59.1471
78217-002-02Hand Sanitizer118.294 mL in 1 BOTTLE, PLASTICGEL118.2941
78217-002-03Hand Sanitizer236.59 mL in 1 BOTTLE, PLASTICGEL236.591
78217-002-04Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
78217-002-05Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78217-002HAND SANITIZER (ALCOHOL) GEL [FRSH HANDS LLC]1Legacy NDC, 5 package rows20200715_aa6c2478-b3b3-a3aa-e053-2a95a90aa83e.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78217-00278217-002-01, 78217-002-02, 78217-002-03, 78217-002-04, 78217-002-05
77808-002

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
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
aa6c24cc-1368-ab29-e053-2a95a90a7690aa6c2478-b3b3-a3aa-e053-2a95a90aa83e2020-07-14WarningsExact identifier
spl id: aa6c24cc-1368-ab29-e053-2a95a90a7690
spl set id: aa6c2478-b3b3-a3aa-e053-2a95a90aa83e

Reported adverse events (FAERS/openFDA)#

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