FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fresh Sanitizer, LLC
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:16

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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) May discolor fabrics.

Label contents#

Full prescribing information#

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 on the skin. 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 consume.

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)
  • May discolor fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

denatonium benzoate, glycerin, hydrogen peroxide, orange flavor, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL

NDC: 80252-100-01

100mL Label100mL Label

3785 mL or 3.785L or 1 Gallon

NDC: 80252-100-02

1gal Label1gal Label

250mL

NDC: 80252-100-03

250mL Label250mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80252-100-012022-01-28C16284748780-1d6a99b39-e426-a426-e053-dadaa90af4c2af72971f-b386-6998-e053-2995a90a9f07
80252-100-022022-01-28C16284748780-1d6a99b39-e426-a426-e053-dadaa90af4c2af72971f-b386-6998-e053-2995a90a9f07
80252-100-032022-01-28C16284748780-1d6a99b39-e426-a426-e053-dadaa90af4c2af72971f-b386-6998-e053-2995a90a9f07

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80252-100-01Hand Sanitizer100 mL in 1 BOTTLESOLUTION1001
80252-100-02Hand Sanitizer3785 mL in 1 CONTAINERSOLUTION37851
80252-100-03Hand Sanitizer250 mL in 1 BOTTLESOLUTION2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80252-100HAND SANITIZER (ALCOHOL) SOLUTION [FRESH SANITIZER, LLC]1Legacy NDC, 3 package rows20201009_af72971f-b386-6998-e053-2995a90a9f07.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
80252-10080252-100-01, 80252-100-02, 80252-100-03

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
DENATONIUM BENZOATE4YK5Z54AT2IACT
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
af729c3d-1f2f-6a2e-e053-2a95a90a338baf72971f-b386-6998-e053-2995a90a9f072020-10-01WarningsExact identifier
spl id: af729c3d-1f2f-6a2e-e053-2a95a90a338b
spl set id: af72971f-b386-6998-e053-2995a90a9f07

Reported adverse events (FAERS/openFDA)#

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