FDA.reportPublic FDA data

Total Solutions Hygien Hand

Manufacturer
Athea Laboratories, Inc.
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:20

Label at a glance#

ProductTotal Solutions Hygien Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

■ For handwashing to help reduce bacteria on skin. ■ After changing diapers. ■ After assisting ill persons. ■ Before contact with a person under medical care or treatment. ■ Recommended for repeat use.

Dosage and administration

■ Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub hands thoroughly. Rinse with water and repeat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ For handwashing to help reduce bacteria on skin. ■ After changing diapers.
■ After assisting ill persons. ■ Before contact with a person under medical care
or treatment. ■ Recommended for repeat use.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in the eyes

OTC - WHEN USING SECTION

When using this product do not get into eyes. If contact occurs, rinse thoroughly with
water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and
forearms. Scrub hands thoroughly. Rinse with water and repeat.

Other information

OTHER SAFETY INFORMATION

■ Store in a cool, dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Poloxamer 124, Lauramidopropylamine Oxide; PEG-3 Cocamide, Hydroxyethylcellulose, Glycerin, Myristamidopropylamine oxide, Benzyl Alcohol, Fragrance, Phenoxyethanol, Citric Acid, FD&C Yellow Number 5, FD&C Red Number 40.

62819-268-01.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62819-260-01.jpg62819-260-01.jpg

62819-268-02.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62819-268-0262819-268-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapPSN4
1053188benzalkonium chloride 1.2 MG/ML Medicated Liquid SoapSCD4
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62819-268-012022-01-30C16284748780-1d6a99b39-d3cd-a426-e053-dadaa90af4c2Total Solutions Hygien Hand Soap
62819-268-022022-01-30C16284748780-1d6a99b39-d3cd-a426-e053-dadaa90af4c2Total Solutions Hygien Hand Soap
62819-268-012022-01-28C16284748780-1d6a99b39-d3cd-a426-e053-dadaa90af4c2Total Solutions Hygien Hand Soap
62819-268-022022-01-28C16284748780-1d6a99b39-d3cd-a426-e053-dadaa90af4c2Total Solutions Hygien Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62819-268-01Total Solutions Hygien Hand3785 mL in 1 BOTTLE, PLASTICSOAP37854
62819-268-02Total Solutions Hygien Hand473 mL in 1 BOTTLE, PLASTICSOAP4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62819-268TOTAL SOLUTIONS HYGIEN HAND (BENZALKONIUM) SOAP [ATHEA LABORATORIES, INC.]4Current NDC, Legacy NDC, 2 package rows20250101_fcd63fe4-a357-4432-a738-ae1bccbb8bae.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62819-26862819-268-01, 62819-268-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLOXAMER 1241S66E28KXAIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)X70SE62ZARIACT
GLYCERINPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
Total Solutions Hygien HandBENZALKONIUMAthea Laboratories, Inc.fcd63fe4-a357-4432-a738-ae1bccbb8bae2024-12-30WarningsExact identifier
ndc (package): 62819-268-01
ndc (package): 62819-268-02
ndc (product): 62819-268
ndc11 (package): 62819026802
ndc11 (package): 62819026801
spl id: 2a8551bf-9018-2a4d-e063-6294a90a15e7
spl set id: fcd63fe4-a357-4432-a738-ae1bccbb8bae

Reported adverse events (FAERS/openFDA)#

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