FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
BT Supplies West Inc
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:09

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. 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. Children under 6 years of age should be supervised by adult when applying this product. Do not use on children less than 2 months of age or on open skin wounds.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 73% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to help reduce bacteria that potentially can cause disease. Recommended for repeated use. For use  when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

do not use in or near eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears on the skin.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Children under 6 years of age should be supervised by adult when applying this product.
  • Do not use on children less than 2 months of age or on open skin wounds.

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C).
  • May discolor ertain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol.

Package Labeling: 473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

77879-002-02 3.8L Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.8L3.8L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287765ethanol 73 % Topical SolutionPSN3
2287765ethanol 0.73 ML/ML Topical SolutionSCD3
2287765ethanol 73 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77879-002-012023-07-28C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer
77879-002-022023-07-28C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer
77879-002-012022-02-09C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer
77879-002-022022-02-09C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer
77879-002-012022-01-28C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer
77879-002-022022-01-28C16284748780-1d6a99b39-da8b-a426-e053-dadaa90af4c2Antibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77879-002-01Antibacterial Hand Sanitizer473 mL in 1 BOTTLELIQUID4733
77879-002-02Antibacterial Hand Sanitizer3800 mL in 1 BOTTLELIQUID38003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77879-002ANTIBACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [BT SUPPLIES WEST INC]3Legacy NDC, 2 package rows20220210_4d597319-4bc2-4281-894a-56d2cbcdd965.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77879-00277879-002-01, 77879-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
PANTHENOLWV9CM0O67ZIACT
INULINJOS53KRJ01IACT
HYALURONATE SODIUMYSE9PPT4THIACT
FRUCTOSE6YSS42VSEVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
d7968e16-8526-a187-e053-2a95a90a7b4e4d597319-4bc2-4281-894a-56d2cbcdd9652022-02-09WarningsExact identifier
spl id: d7968e16-8526-a187-e053-2a95a90a7b4e
spl set id: 4d597319-4bc2-4281-894a-56d2cbcdd965

Reported adverse events (FAERS/openFDA)#

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