FDA.reportPublic FDA data

Abutol ANTISEPTIC HAND WASH Pomegranate and Tangerine

Manufacturer
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI
Effective date
2020-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:30

Label at a glance#

ProductAbutol ANTISEPTIC HAND WASH Pomegranate and Tangerine
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

● wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds ● rinse and repeat ● 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 0.12%

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 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds
● rinse and repeat
● 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 ingredients

INACTIVE INGREDIENT SECTION

Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Red No. 40, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

with Moisturizer

Pomegranate & Tangerine -Cleans and softens hands

Distributed by:
American Brands and More
LLC, Wood Ridge, NJ 07075

Made in TURKEY
You may also report any serious side effects to

PO Box 328, Wood Ridge, NJ 07075-328

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unitledunitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapPSN1
1053188benzalkonium chloride 1.2 MG/ML Medicated Liquid SoapSCD1
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77418-206-202022-01-28C16284748780-1d6a99b39-e6f6-a426-e053-dadaa90af4c2Abutol PARIS ANTISEPTIC HAND WASH Pomegranate & Tangerine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77418-206-20Abutol ANTISEPTIC HAND WASH Pomegranate and Tangerine500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77418-206ABUTOL ANTISEPTIC HAND WASH POMEGRANATE AND TANGERINE (BENZALKONIUM CHLORIDE) LIQUID [ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI]1Legacy NDC, 1 package rows20201203_65fdb0c3-d9aa-4857-9e94-6bd8b0f577f9.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77418-20677418-206-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SULISOBENZONE1W6L629B4KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DMDM HYDANTOINBYR0546TOWIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
EDETATE SODIUMMP1J8420LUIACT

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
bca4ced7-1a52-47a1-a3cd-bc3a625bd29b65fdb0c3-d9aa-4857-9e94-6bd8b0f577f92020-11-02WarningsExact identifier
spl id: bca4ced7-1a52-47a1-a3cd-bc3a625bd29b
spl set id: 65fdb0c3-d9aa-4857-9e94-6bd8b0f577f9

Reported adverse events (FAERS/openFDA)#

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