FDA.reportPublic FDA data

Germicidal Hand Softening Gel Benzalkonium Chloride

Manufacturer
fiteBac SkinCare, LLC | CBI Laboratories, Inc. | AmeriPac, Inc.
Effective date
2011-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:15

Label at a glance#

ProductfiteBac SkinCare Germicidal Hand Softening
Active ingredientBenzalkonium Chloride
Label structure11 sections

Indications and uses

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

Dosage and administration

Use only a small, pea-sized amount as needed, which is enough to cover both your hands. Rub thoroughly over all surfaces of both hands

Storage and handling

Not intended to provide ongoing protection against new germ exposure

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask 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

  • Use only a small, pea-sized amount as needed, which is enough to cover both your hands.
  • Rub thoroughly over all surfaces of both hands

Other Information

STORAGE AND HANDLING SECTION

  • Not intended to provide ongoing protection against new germ exposure

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethacone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride

Questions, comments, side effects or reordering

OTC - QUESTIONS SECTION

1-855-222-1640.

SPL UNCLASSIFIED SECTION

Distributed by fiteBac SkinCare, LLC, Marietta, Georgia 30064

PRINCIPAL DISPLAY PANEL - 85.05 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GERMICIDAL
HAND SOFTENING GEL
Benzalkonium Chloride

fiteBac™
SkinCare
"A little bit goes a long way"

  • Kills Bacteria
  • Non-Greasy
  • Petroleum Free
  • Hydrophobic
  • Alcohol Free
  • Fragrance Free
  • Water Free
  • Cost-Effective

Unique patent pending formulation kills
bacteria while helping to strengthen
the skin's moisture barrier. Helps keep
skin velvety soft, even after frequent
handwashing or exposure to gloves or
other harsh environments.

NET WT 3.0 OZ (85.05g)

www.fiteBac.com

Principal Display Panel - 85.05 g Tube Label
Principal Display Panel - 85.05 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN1
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD1
1049228benzalkonium chloride 0.1 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13136-001-012019-11-13C16284748780-197449f38-d3b5-f6ea-e053-dbdaa90aa703Germicidal Hand Softening Gel Benzalkonium Chloride
13136-001-022019-11-13C16284748780-197449f38-d3b5-f6ea-e053-dbdaa90aa703Germicidal Hand Softening Gel Benzalkonium Chloride
13136-001-032019-11-13C16284748780-197449f38-d3b5-f6ea-e053-dbdaa90aa703Germicidal Hand Softening Gel Benzalkonium Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13136-001-01fiteBac SkinCare Germicidal Hand Softening29.57 mL in 1 TUBEGEL29.571
13136-001-02fiteBac SkinCare Germicidal Hand Softening88.72 mL in 1 TUBEGEL88.721
13136-001-03fiteBac SkinCare Germicidal Hand Softening236.59 mL in 1 BOTTLE, PLASTICGEL236.591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13136-001FITEBAC SKINCARE GERMICIDAL HAND SOFTENING (BENZALKONIUM CHLORIDE) GEL [FITEBAC SKINCARE, LLC]1Legacy NDC, 3 package rows20111205_f217e09b-8d3c-40c4-8ab2-a7644c87b803.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13136-00113136-001-01, 13136-001-02, 13136-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Cyclomethicone 50THT5PCI0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
cb18242d-5906-42e3-8212-d704e92ea43bf217e09b-8d3c-40c4-8ab2-a7644c87b8032011-11-10WarningsExact identifier
spl id: cb18242d-5906-42e3-8212-d704e92ea43b
spl set id: f217e09b-8d3c-40c4-8ab2-a7644c87b803

Reported adverse events (FAERS/openFDA)#

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