FDA.reportPublic FDA data

HydrAphex

Manufacturer
Aphex Biocleanse Systems, Inc | Aphex BioCleanse Systems
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#

ProductHydrAphex
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

Dosage and Admnstration

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%

Usage Section

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

Keep Out of Reach of Children

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

(As sanitizing agent)

Purpose Section

OTC - PURPOSE SECTION

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

(As sanitizing agent)

HydrAphex Hanad Sanitizer 275 Gallon

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydrAphex 275 GallonHydrAphex 275 Gallon

HydrAphex 55 Gallon Drum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydrAphex 55 GallonHydrAphex 55 Gallon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78003-140-70HydrAphex208000 mL in 1 DRUMSOLUTION2080002
78003-140-80HydrAphex1045000 mL in 1 CONTAINERSOLUTION10450002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78003-140HYDRAPHEX SOLUTION [APHEX BIOCLEANSE SYSTEMS, INC]2Current NDC, Legacy NDC, 2 package rows20220118_a6035c7d-0f5b-3295-e053-2995a90af89c.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
78003-14078003-140-80, 78003-140-70

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
WATER059QF0KO0RIACT
UREA8W8T17847WIACT
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
HydrAphexHYDRAPHEXAphex Biocleanse Systems, Inca6035c7d-0f5b-3295-e053-2995a90af89c2022-01-17WarningsExact identifier
ndc (package): 78003-140-70
ndc (package): 78003-140-80
ndc (product): 78003-140
ndc11 (package): 78003014070
ndc11 (package): 78003014080
spl id: d5ccc62d-3d96-650c-e053-2a95a90a5e17
spl set id: a6035c7d-0f5b-3295-e053-2995a90af89c

Reported adverse events (FAERS/openFDA)#

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