SHSNH6-5111 Alcohol-Free Foaming Hand Sanitizer Antimicrobial Foaming Solution

Manufacturer
Shotwell Hydrogenics, LLC
Effective date
2020-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:11

Label at a glance#

ProductSHSNH6-5111
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

• Pump a small amount of foam into palm of hand. • Rub thoroughly over all surfaces of both hands • Continue to rub hands until dry.

Label contents#

Full prescribing information#

Active ingredients(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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.

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask for a doctor if irritation or redness develops, or if condition persists 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

• Pump a small amount of foam into palm of hand.

• Rub thoroughly over all surfaces of both hands

• Continue to rub hands until dry.

Inactive ingredients

INACTIVE INGREDIENT SECTION

deionized water, glycerin, aloe barbadensis leaf juice, lauramine oxide, dimethyltetradecylamine oxide, fragrance, DMDM hydantoin (preservative).

SPL UNCLASSIFIED SECTION

Alcohol-Free Foaming Hand Sanitizer

Antimicrobial Foaming Solution

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN2
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD2
1020365benzalkonium chloride 0.13 % Topical FoamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73870-201-332022-01-28C16284748780-1d6a99b39-b44b-a426-e053-dadaa90af4c2SHSNH6-5111 Alcohol-Free Foaming Hand Sanitizer Antimicrobial Foaming Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73870-201-33SHSNH6-51111249 L in 1 CONTAINERSOLUTION12492

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73870-201SHSNH6-5111 (BENZALKONIUM CHLORIDE) SOLUTION [SHOTWELL HYDROGENICS, LLC]2Legacy NDC, 1 package rows20201125_49fe8dbb-98e7-4204-8de8-2d28aec54f63.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73870-20173870-201-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
3ac67aef-4a2a-4959-bdd9-b4f5cd3c5b4449fe8dbb-98e7-4204-8de8-2d28aec54f632020-11-23WarningsExact identifier
spl id: 3ac67aef-4a2a-4959-bdd9-b4f5cd3c5b44
spl set id: 49fe8dbb-98e7-4204-8de8-2d28aec54f63

Reported adverse events (FAERS/openFDA)#

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