FDA.reportPublic FDA data

Antibacterial Foaming Hand Sanitizer

Manufacturer
Maketa,LLC | BMC 1092, Inc. dba Solo Laboratories, Inc.
Effective date
2020-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:56

Label at a glance#

ProductAntibacterial Foaming Hand Sanitizer
Active ingredientBenzalkonium Chloride
Label structure10 sections

Indications and uses

Sanitizes hands to help reduce bacteria that potentially cause diseases.

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until hands are entirely dry.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Sanitizes hands to help reduce bacteria that potentially cause diseases.

Warnings

WARNINGS SECTION

For External use only. Use on hands only. Do not use over large areas of the body.

OTC - DO NOT USE SECTION

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop Use and ask a doctor if irritation and redness develops , or persist for more than 72 hours.

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 in your palm to thoroughly cover your hands. Rub hands together briskly until hands are entirely dry.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Leaf Juice, Water, Glycerin, Aloe Barbadensis Bisabolol , PEG-8, Disodium EDTA, Polysorbate-20, PEG-40, Sorbitan Peroleate, Allantoin, Sodium Benzoate, Fragrance

Questions?

OTC - QUESTIONS SECTION

(800) 638-8149

PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Makéta™

antimicrobial
FOAMING HAND
SANITIZER

kills 99.99%
of all germs

9.5 fl. oz. (281 ml)

PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 281 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN1
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD1
1020365benzalkonium chloride 0.13 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72102-056-092022-01-28C16284748780-1d6a99b39-3a68-a426-e053-dadaa90af4c2Antibacterial Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72102-056-09Antibacterial Foaming Hand Sanitizer281 mL in 1 BOTTLELIQUID2811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72102-056ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [MAKETA,LLC]1Legacy NDC, 1 package rows20200420_52288ed3-1a3a-4852-8c88-3bb4c9599bb0.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72102-05672102-056-09

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
Benzalkonium ChlorideF5UM2KM3W7ACTIB
water059QF0KO0RIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
Allantoin344S277G0ZIACT
Aloe vera leafZY81Z83H0XIACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
PEG-8 Stearate2P9L47VI5EIACT
PEG-40 Sorbitan diisostearateJL4CCU7I1GIACT
GlycerinPDC6A3C0OXIACT
Sodium BenzoateOJ245FE5EUIACT
Polysorbate 207T1F30V5YHIACT

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
f58848b5-0b74-468a-8955-523eac024b5552288ed3-1a3a-4852-8c88-3bb4c9599bb02020-04-07WarningsExact identifier
spl id: f58848b5-0b74-468a-8955-523eac024b55
spl set id: 52288ed3-1a3a-4852-8c88-3bb4c9599bb0

Reported adverse events (FAERS/openFDA)#

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