FDA.reportPublic FDA data

SONO Hand Sanitizer

Manufacturer
Advanced Ultrasound Solutions Inc. | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:30

Label at a glance#

ProductSONO Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

Hand sanitizer to help reduce bacteria on skin Recommended for repeated use

Dosage and administration

Apply a small amount onto hand, then spread on both hands Rub hands together until dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride.........0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Do not use in ears or mouth

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

If redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children should be supervised when using this product

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a small amount onto hand, then spread on both hands
  • Rub hands together until dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, PEG/PPG-18/18 Dimethicone, water, Organic Citrus Aurantium Bergamia Fruit Oil.

Sono Foaming Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description
image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN3
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD3
1020365benzalkonium chloride 0.13 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77677-001-022025-01-30C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer
77677-001-192025-01-30C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer
77677-001-022023-06-14C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer
77677-001-192023-06-14C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer
77677-001-022022-01-28C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer
77677-001-192022-01-28C16284748780-1d6a99b39-dd64-a426-e053-dadaa90af4c2SONO Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77677-001-02SONO Hand Sanitizer50 g in 1 BOTTLESOLUTION503
77677-001-19SONO Hand Sanitizer550 g in 1 BOTTLESOLUTION5503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77677-001SONO HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [ADVANCED ULTRASOUND SOLUTIONS INC.]3Legacy NDC, 2 package rows20231215_dc374be3-c586-4f88-812a-622239a3a3b7.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
77677-00177677-001-02, 77677-001-19

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
WATER059QF0KO0RIACT
BERGAMOT OIL39W1PKE3JIIACT

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
2744ceab-4d59-4cad-bfc3-ccb05b9ea7bfdc374be3-c586-4f88-812a-622239a3a3b72023-12-14WarningsExact identifier
spl id: 2744ceab-4d59-4cad-bfc3-ccb05b9ea7bf
spl set id: dc374be3-c586-4f88-812a-622239a3a3b7

Reported adverse events (FAERS/openFDA)#

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