FDA.reportPublic FDA data

SoftenSure Foam Antimicrobial

Manufacturer
Best Sanitizers, Inc.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:00

Label at a glance#

ProductSoftenSure Foam Antimicrobial
Active ingredientCHLOROXYLENOL
Label structure9 sections

Storage and handling

Other information store in a cool, dry place below 104 o F (40 o C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Chloroxylenol 1.0%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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 ifirritation and redness develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information

store in a cool, dry place below 104 oF (40 oC)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

OTC - QUESTIONS SECTION

Questions?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

versaclenz compatible

SoftenSure

foam soap

antimicrobial

BEST

SANITIZERS

INC.

Net Contents:

container labelcontainer label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413257chloroxylenol 1 % Medicated Liquid SoapPSN2
413257chloroxylenol 10 MG/ML Medicated Liquid SoapSCD2
413257chloroxylenol 1 % Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59900-127-05SoftenSure Foam Antimicrobial1250 mL in 1 BOXLIQUID12502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59900-127SOFTENSURE FOAM ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [BEST SANITIZERS, INC.]2Current NDC, Legacy NDC, 1 package rows20241218_ac49f166-beba-4a9d-86c1-15f016a26665.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
59900-12759900-127-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
EDETATE SODIUMMP1J8420LUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB

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 Foam AntimicrobialCHLOROXYLENOLBest Sanitizers, Inc.ac49f166-beba-4a9d-86c1-15f016a266652024-12-05WarningsExact identifier
ndc (package): 59900-127-05
ndc (product): 59900-127
ndc11 (package): 59900012705
spl id: 288cc670-820e-8336-e063-6394a90a46bf
spl set id: ac49f166-beba-4a9d-86c1-15f016a26665

Reported adverse events (FAERS/openFDA)#

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