FDA.reportPublic FDA data

WIEBERR ® ANTISEPTIC HAND SANITIZER GEL

Manufacturer
KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:37

Label at a glance#

ProductANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

▪ hand sanitizer to decrease bacteria on the skin ▪ recommended for repeated use ▪ for use when soap and water are not available

Dosage and administration

▪ wet hands thoroughly with product and allow to dry without wiping ▪ 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

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

▪ hand sanitizer to decrease bacteria on the skin

▪ recommended for repeated use

▪ for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

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 thoroughly with product and allow to dry without wiping

▪ 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

carbomer, glycerin, water

Questions?

OTC - QUESTIONS SECTION

+1-410-441-4610

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Quality in our chemistry

Empty packaging way of dispose: Properly dispose of accordance the rule.

Ministry of Health License Date and Number 27.03.2020-202079

Manufactured for:

KOÇKAR

Makina Kimya San. ve Tic. A.S.

Fatih Mh. 9008 Sk. No: 121

AkyazI, SAKARYA, TURKEY 54400

COUNTRY OF ORIGIN: TURKEY

www.wieberr.com.tr / info@wieberr.com.tr

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78433-101-012021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-022021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-032021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-042021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-052021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-062021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-072021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-082021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-092021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-102021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-112021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-122021-07-23C16284748780-1c7ccaba7-1c02-fd44-e053-dadaa90aa01bWIEBERR ® ANTISEPTIC HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78433-101-01ANTISEPTIC HAND SANITIZER5 mL in 1 BOTTLEGEL51
78433-101-02ANTISEPTIC HAND SANITIZER10 mL in 1 BOTTLEGEL101
78433-101-03ANTISEPTIC HAND SANITIZER50 mL in 1 BOTTLEGEL501
78433-101-04ANTISEPTIC HAND SANITIZER100 mL in 1 BOTTLEGEL1001
78433-101-05ANTISEPTIC HAND SANITIZER200 mL in 1 BOTTLEGEL2001
78433-101-06ANTISEPTIC HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78433-101-07ANTISEPTIC HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78433-101-08ANTISEPTIC HAND SANITIZER750 mL in 1 BOTTLEGEL7501
78433-101-09ANTISEPTIC HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
78433-101-10ANTISEPTIC HAND SANITIZER5000 mL in 1 BOTTLEGEL50001
78433-101-11ANTISEPTIC HAND SANITIZER20000 mL in 1 CONTAINERGEL200001
78433-101-12ANTISEPTIC HAND SANITIZER1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78433-101ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 12 package rows20200717_173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78433-10178433-101-01, 78433-101-02, 78433-101-03, 78433-101-04, 78433-101-05, 78433-101-06, 78433-101-07, 78433-101-08, 78433-101-09, 78433-101-10, 78433-101-11, 78433-101-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
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
a981dc46-3c36-4f3d-80a9-691747e50800173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d2020-07-07WarningsExact identifier
spl id: a981dc46-3c36-4f3d-80a9-691747e50800
spl set id: 173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d

Reported adverse events (FAERS/openFDA)#

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