FDA.reportPublic FDA data

UNIT - SOFT antiseptic hand wash

Manufacturer
YUNITOR, OOO
Effective date
2020-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:46

Label at a glance#

ProductUNIT - SOFT antiseptic hand wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

■ for handwashing to decrease bacteria on the skin ■ recommended for repeated use

Dosage and administration

■ wet hands and forearms. Apply 1.5 ml to hands and forearms and foam. Scrub thoroughly for 1 minute, rinse and dry with towel, paper towel or hot air ■ supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

■ store between 15-30°C (59-86°F) ■ avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

■ for handwashing to decrease bacteria on the skin

■ recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Do not use

■ in children less than 2 months of age

■ on open skin wounds

When using this product ■ do not get into eyes.In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

■ irritation and redness develop

■ 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

■ wet hands and forearms. Apply 1.5 ml to hands and forearms and foam. Scrub thoroughly for 1 minute, rinse and dry with towel, paper towel or hot air

■ supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

■ store between 15-30°C (59-86°F)

■ avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients chamomile extract, citric acid, cocamidopropyl betaine, disodium EDTA, D-panthenol, fragrance, glycerin,

hydroxyethylcellulose, methylchloroisothiazolinone, 1,2-propylene glycol, sodium chloride, water

OTC - QUESTIONS SECTION

Questions? +1-404-795-4774

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Manufactured by: YUNITOR, OOO

d. 91 kv. 1, ul. Rabochaya, Bataisk,

Russian Federation, RU 346885

Made in Russia

Tel.: +7 (863) 333-35-31.

Email: www.fdpro.com, info@fdpro.com

Legal address:YUNITOR, OOO

d. 91 kv. 1, ul. Rabochaya, Bataisk,

Russian Federation, RU 346885

Claim for quality to:YUNITOR, OOO

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2396753benzalkonium chloride 1 % Medicated Liquid SoapPSN1
2396753benzalkonium chloride 10 MG/ML Medicated Liquid SoapSCD1
2396753benzalkonium chloride 1 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80407-101-052022-01-28C16284748780-1d6a99b39-60c1-a426-e053-dadaa90af4c2UNIT - SOFT ANTISEPTIC HAND WASH
80407-101-102022-01-28C16284748780-1d6a99b39-60c1-a426-e053-dadaa90af4c2UNIT - SOFT ANTISEPTIC HAND WASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80407-101-05UNIT - SOFT antiseptic hand wash500 mL in 1 BOTTLE, PLASTICLIQUID5001
80407-101-10UNIT - SOFT antiseptic hand wash1000 mL in 1 BOTTLE, PLASTICLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80407-101UNIT - SOFT ANTISEPTIC HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [YUNITOR, OOO]1Legacy NDC, 2 package rows20200919_ceb1f653-8d03-4f36-9b5c-07519cc79fe7.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80407-10180407-101-05, 80407-101-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DEXPANTHENOL1O6C93RI7ZIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

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
613d0f93-b705-43c8-abb3-d5af53d2e18aceb1f653-8d03-4f36-9b5c-07519cc79fe72020-09-15WarningsExact identifier
spl id: 613d0f93-b705-43c8-abb3-d5af53d2e18a
spl set id: ceb1f653-8d03-4f36-9b5c-07519cc79fe7

Reported adverse events (FAERS/openFDA)#

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