FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Bell Food & Beverage Inc.
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:27

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)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, CI-42090, Ethyl Macadamiate, Eucalyptus Globulus Leaf Oil, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Safflower Glyceride, Tocopheryl Acetate, Water, 1,2-Hexanediol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml label500ml label500 mL NDC: 73806-0004-1

1892 mL NDC: 73806-0004-2 1892mL Label1892mL Label

3785mL NDC: 73806-0004-3

3785 mL Label3785 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73806-0004-12023-01-30C16284748780-1f386c649-ba63-0266-e053-dadaa90a7c1ab48ec9d5-6641-c01e-e053-2a95a90a5afd
73806-0004-22023-01-30C16284748780-1f386c649-ba63-0266-e053-dadaa90a7c1ab48ec9d5-6641-c01e-e053-2a95a90a5afd
73806-0004-32023-01-30C16284748780-1f386c649-ba63-0266-e053-dadaa90a7c1ab48ec9d5-6641-c01e-e053-2a95a90a5afd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73806-0004-1Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001
73806-0004-2Hand Sanitizer1892 mL in 1 BOTTLE, PUMPGEL18921
73806-0004-3Hand Sanitizer3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73806-0004HAND SANITIZER (ALCOHOL) GEL [BELL FOOD & BEVERAGE INC.]1Legacy NDC, 3 package rows20201202_b48ec9d5-6641-c01e-e053-2a95a90a5afd.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73806-000473806-0004-1, 73806-0004-2, 73806-0004-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYL MACADAMIATEANA2NCS6V1IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYSORBATE 806OZP39ZG8HIACT
SAFFLOWER OIL65UEH262ISIACT
EUCALYPTUS OIL2R04ONI662IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERINPDC6A3C0OXIACT

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
b48ec4e3-cea5-5467-e053-2995a90aa950b48ec9d5-6641-c01e-e053-2a95a90a5afd2020-11-20WarningsExact identifier
spl id: b48ec4e3-cea5-5467-e053-2995a90aa950
spl set id: b48ec9d5-6641-c01e-e053-2a95a90a5afd

Reported adverse events (FAERS/openFDA)#

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