FDA.reportPublic FDA data

DermaCen Non-Alcohol Foaming Hand Sanitizer

Manufacturer
Central Solutions Inc
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:41:30

Label at a glance#

ProductDermaCen Non-Alcohol Foaming Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

INDICATIONS & USAGE SECTION

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a physician or Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Pump a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together briskly until dry

INACTIVE INGREDIENT SECTION

Inactive ingredients

Purified Water, Glycerin, Cocamidopropyl Betaine, Triethanolamine

OTC - PURPOSE SECTION

Purpose

Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaCen

Non-Alcohol

Foaming Instant

Hand Sanitizer

For hand sanitizing

to decrease bacteria

on the skin

NET CONTENTS: 18 ounces (532 mL)

container labelcontainer label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN5
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD5
1020365benzalkonium chloride 0.13 % Topical FoamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62654-141-14DermaCen Non-Alcohol Foaming Hand Sanitizer532 mL in 1 BOTTLE, PUMPSOLUTION5325
62654-141-16DermaCen Non-Alcohol Foaming Hand Sanitizer1000 mL in 1 BOTTLE, PUMPSOLUTION10005
62654-141-37DermaCen Non-Alcohol Foaming Hand Sanitizer532 mL in 1 BOTTLESOLUTION5325

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62654-141DERMACEN NON-ALCOHOL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [CENTRAL SOLUTIONS INC]5Current NDC, Legacy NDC, 3 package rows20241210_c7aa7ea9-7937-45bb-b32e-dd644dbf764e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W72
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y2
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KX2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62654-14162654-141-14, 62654-141-16, 62654-141-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
4 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
DermaCen Non-Alcohol Foaming Hand SanitizerBENZALKONIUM CHLORIDECentral Solutions Incc7aa7ea9-7937-45bb-b32e-dd644dbf764e2024-12-09WarningsExact identifier
ndc (package): 62654-141-16
ndc (package): 62654-141-37
ndc (package): 62654-141-14
ndc (product): 62654-141
ndc11 (package): 62654014116
ndc11 (package): 62654014137
ndc11 (package): 62654014114
spl id: 28d99f72-d42b-dd95-e063-6294a90a3708
spl set id: c7aa7ea9-7937-45bb-b32e-dd644dbf764e

Reported adverse events (FAERS/openFDA)#

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