DermAphex Hand Sanitizer

Manufacturer
Aphex Biocleanse Systems, Inc
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:06

Label at a glance#

ProductDermAphex Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Uses: For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Dosage and administration

Directions: Refill your container. 1 - 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands. Continue rubbing until dry. Use frequently to avoid spreading germs.

Label contents#

Full prescribing information#

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Refill your container. 1 - 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands. Continue rubbing until dry.

Use frequently to avoid spreading germs.

Warnings

WARNINGS SECTION

Warnings:

For External Use Only
Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns.
If swallowed, get medical help or contact a poison control center right away.
Keep Out of Reach of Children

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredients: -Water 99.83% -Carbamide to 0.04%

Indications and Usage

INDICATIONS & USAGE SECTION

Uses: For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings:

For External Use Only
Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns.
If swallowed, get medical help or contact a poison control center right away.
Keep Out of Reach of Children

Purpose

OTC - PURPOSE SECTION

Active ingredients: Benzalkonium Chloride 0.11% - 0 .13%

(As sanitizing agent)

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Benzalkonium Chloride 0.11% - 0 .13%

(As sanitizing agent)

DermAphex 275 Gallon Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermAphex275GalDermAphex275Gal

DermAphex 55 Gallon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermAphex55GalDermAphex55Gal

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78003-120-702023-07-28C16284748780-10191ceaa-724c-198a-e063-dbdaa90aec3eDermAphex Hand Sanitizer
78003-120-802023-07-28C16284748780-10191ceaa-724c-198a-e063-dbdaa90aec3eDermAphex Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78003-120-70DermAphex Hand Sanitizer208000 mL in 1 DRUMSOLUTION2080002
78003-120-80DermAphex Hand Sanitizer1054000 mL in 1 CONTAINERSOLUTION10540002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78003-120DERMAPHEX HAND SANITIZER SOLUTION [APHEX BIOCLEANSE SYSTEMS, INC]2Legacy NDC, 2 package rows20220118_a8c90a99-0e22-5ea1-e053-2a95a90a4a3e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78003-12078003-120-80, 78003-120-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
d5cce7f7-0853-15aa-e053-2a95a90a3cc3a8c90a99-0e22-5ea1-e053-2a95a90a4a3e2022-01-17WarningsExact identifier
spl id: d5cce7f7-0853-15aa-e053-2a95a90a3cc3
spl set id: a8c90a99-0e22-5ea1-e053-2a95a90a4a3e

Reported adverse events (FAERS/openFDA)#

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