SoftenSure Antimicrobial Foam

Manufacturer
Best Sanitizers, Inc
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:43:03

Label at a glance#

ProductSoftenSure Antimicrobial Foam
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• handwash to help reduce bacteria that potentially can cause disease • helps to prevent cross-contamination by hand contact • helps to prevent drying of the skin • recommended for repeated use

Dosage and administration

• wet hands and wrists with potable water • apply appropriate amount of product • lather and scrub hands, fingers, fingernails, cuticles, and wrists for at least 20 seconds • rinse thoroughly with potable water before handling food • dry hands completely (incomplete drying may result in chapped skin)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Purpose

OTC - PURPOSE SECTION

Antiseptic Hand Cleanser

Uses

INDICATIONS & USAGE SECTION

• handwash to help reduce bacteria that potentially can cause disease

• helps to prevent cross-contamination by hand contact

• helps to prevent drying of the skin

• recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• wet hands and wrists with potable water

• apply appropriate amount of product

• lather and scrub hands, fingers, fingernails, cuticles, and wrists for at least 20 seconds

• rinse thoroughly with potable water before handling food

• dry hands completely (incomplete drying may result in chapped skin)

Other information

OTHER SAFETY INFORMATION

store in a cool, dry place below 104° F (40° C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cocamidopropyl betaine, glycerine, polyethylene-polypropylene glycol, benzyl alcohol, phenoxyethanol, tetrasodium EDTA, dehydroacetic acid, sodium hydroxide, citric acid

Questions?

OTC - QUESTIONS SECTION

Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am-4 pm PST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

foam

soap

Soften

Sure

ANTIMICROBIAL

FOAM SOAP

Benzalkonium Chloride •

Fragrance and Dye Free •

For Professional Use •

NSF

Nonfood Compounds

Program Listed (E2)

Registration #166522

KC

PAREVE

Net Contents: 500mL (16.9 FL OZ)

container labelcontainer label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59900-216-01SoftenSure Antimicrobial Foam500 mL in 1 BOTTLELIQUID5001
59900-216-02SoftenSure Antimicrobial Foam500 mL in 1 BOTTLELIQUID5001
59900-216-02SoftenSure Antimicrobial Foam12 in 1 CASELIQUID121
59900-216-03SoftenSure Antimicrobial Foam1200 mL in 1 BOTTLELIQUID12001
59900-216-04SoftenSure Antimicrobial Foam4 in 1 CASELIQUID41
59900-216-04SoftenSure Antimicrobial Foam1200 mL in 1 BOTTLELIQUID12001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59900-216SOFTENSURE ANTIMICROBIAL FOAM (BENZALKONIUM CHLORIDE) LIQUID [BEST SANITIZERS, INC]1Current NDC, 6 package rows20241215_29286676-a07f-78e3-e063-6294a90a4ac5.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
59900-21659900-216-01, 59900-216-02, 59900-216-03, 59900-216-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
SoftenSure Antimicrobial FoamBENZALKONIUM CHLORIDEBest Sanitizers, Inc29286676-a07f-78e3-e063-6294a90a4ac52024-12-13WarningsExact identifier
ndc (package): 59900-216-02
ndc (package): 59900-216-03
ndc (package): 59900-216-04
ndc (package): 59900-216-01
ndc (product): 59900-216
ndc11 (package): 59900021604
ndc11 (package): 59900021603
ndc11 (package): 59900021602
ndc11 (package): 59900021601
spl id: 29286676-a080-78e3-e063-6294a90a4ac5
spl set id: 29286676-a07f-78e3-e063-6294a90a4ac5

Reported adverse events (FAERS/openFDA)#

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