80% Hand Sanitizer

Manufacturer
FAB DISTRO UNLIMITED, LLC. | FAB DISTRO UNLIMITED, LLC
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:47

Label at a glance#

Product80% Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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. Highly flammable liquid and vapor. Causes serious eye irritation. Keep away from heat or flame.

Do Not Use

OTC - DO NOT USE SECTION

  • If you are allergic to any of the ingredients
  • In children less than 2 months of age
  • On open skin wounds

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use or ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

PRECAUTIONS SECTION

  • Keep away from heat/sparks/open flame/hot surfaces.
  • No Smoke. Keep container tightly closed.
  • Avoid breathing vapors/mist/spray.
  • Contaminated work clothing should not be allowed out of the workplace.
  • Wear protective eye protection/face protection.
  • Store in a well-ventilated place. Keep cool.
  • Dispose of contents/container to a licensed treatment, storage or disposal facility (TSRF)
  • If in eyes rinse continuously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
  • In case of fire use CO2, Halon (if permitted), dry chemical, or foam for extinction.

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydrogen peroxide, purified water USP

80% Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78339-100-012022-01-28C16284748780-1d6a99b39-da40-a426-e053-dadaa90af4c280% Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78339-100-0180% Hand Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78339-10080% HAND SANITIZER (ETHYL ALCOHOL) GEL [FAB DISTRO UNLIMITED, LLC.]1Legacy NDC, 1 package rows20200527_a681255a-6813-1e61-e053-2a95a90a7bf3.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
78339-10078339-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
a68137c1-3a9b-1525-e053-2a95a90a9c52a681255a-6813-1e61-e053-2a95a90a7bf32020-05-25WarningsExact identifier
spl id: a68137c1-3a9b-1525-e053-2a95a90a9c52
spl set id: a681255a-6813-1e61-e053-2a95a90a7bf3

Reported adverse events (FAERS/openFDA)#

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