FDA.reportPublic FDA data

first depHense Alcohol-Free Antiseptic Foam Hand Sanitizer

Manufacturer
First Dephense, LLC | American Blending and Filling
Effective date
2011-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:35

Label at a glance#

Productfirst depHense Alcohol-Free Antiseptic Foam Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use in eyes. If contact occurs, flush eyes with water.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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.

DOSAGE & ADMINISTRATION SECTION

Directions
  • Pump a small amount of foam into palm of hand.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Rub hands together briskly until dry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

SPL UNCLASSIFIED SECTION

Distributed by first depHense, LLC
519 S. Main St., Sycamore, IL 60178

Made in USA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • NO RINSE
  • MOISTURIZES
  • LEAVES SKIN SOFT

Up To 3 Times MORE APPLICATIONS
THAN ALCOHOL-BASED GELS



first depHense
Protecting your health and environment

ALCOHOL-FREE
Antiseptic Foam Hand Sanitizer

Eliminates 99.999%
OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS


Environmentally  Friendly
1.7 floz (50ml)

HandSanitizer
HandSanitizer

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
76116-100-012019-10-29C16284748780-1960f7f55-d86e-8e05-e053-dbdaa90a074afirst depHense ALCOHOL-FREE Antiseptic Foam Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76116-100-01first depHense Alcohol-Free Antiseptic Foam Hand Sanitizer50 mL in 1 BOTTLE, PUMPLIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76116-100FIRST DEPHENSE ALCOHOL-FREE ANTISEPTIC FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [FIRST DEPHENSE, LLC]1Legacy NDC, 1 package rows20110329_fc9c0cba-c806-4991-89eb-6a304fbfbb1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
BEHENTRIMONIUM CHLORIDEINACTIVE INGREDIENTX7GNG3S47T1
DIHYDROXYETHYL COCAMINE OXIDEINACTIVE INGREDIENT8AR51R3BL51
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDEINACTIVE INGREDIENT0Y0NQR2GH11
GLYCERETH-2 COCOATEINACTIVE INGREDIENTJWM00VS7HC1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76116-10076116-100-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT

Source Document#

Source XML · Source PDF

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
1d35322c-192f-4926-86d2-21720ec7b06afc9c0cba-c806-4991-89eb-6a304fbfbb1d2011-03-28WarningsExact identifier
spl id: 1d35322c-192f-4926-86d2-21720ec7b06a
spl set id: fc9c0cba-c806-4991-89eb-6a304fbfbb1d

Reported adverse events (FAERS/openFDA)#

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