FDA.reportPublic FDA data

WANCARE ONEHAND ANTISEPTIC HAND GEL

Manufacturer
KAF GRUP SAGLIK HIZMETLERI INSAAT SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:40

Label at a glance#

ProductWANCARE ONEHAND ANTISEPTIC HAND Gel
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store between 5-40C (41-104F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Do not use

   •   in children less than 2 months of age
   •   on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water.  Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash appears and lasts. 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

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

Store between 5-40C (41-104F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Fragrance 

SPL UNCLASSIFIED SECTION

70% ALCOHOL

Topical Gel

Manufacturer and License Owner:

KAF GRUP SAGLIK HIZMETLERI

INSAAT SANAYI VE TIC. LTD. STI.

Atakent Mah. 221. Sk. No:3A Rota Office A Blok

D:83

K.CEKMECE -ISTANBUL/TURKEY

Tel: +90 212 471 4 200

Fax: +90 212 471 4 201

www.kafgrup.com / info@kafgrup.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackaging

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
81314-201-012024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL
81314-201-022024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL
81314-201-032024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL
81314-201-042024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL
81314-201-052024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL
81314-201-062024-01-30C16284748780-11030e365-0bef-111a-e063-dadaa90a10e2WANCARE ONEHAND ANTISEPTIC HAND GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81314-201-01WANCAREONEHAND ANTISEPTIC HAND Gel5 mL in 1 PACKETGEL51
81314-201-02WANCAREONEHAND ANTISEPTIC HAND Gel50 mL in 1 BOTTLEGEL501
81314-201-03WANCAREONEHAND ANTISEPTIC HAND Gel100 mL in 1 BOTTLEGEL1001
81314-201-04WANCAREONEHAND ANTISEPTIC HAND Gel250 mL in 1 BOTTLEGEL2501
81314-201-05WANCAREONEHAND ANTISEPTIC HAND Gel500 mL in 1 BOTTLEGEL5001
81314-201-06WANCAREONEHAND ANTISEPTIC HAND Gel1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81314-201WANCARE ONEHAND ANTISEPTIC HAND GEL (ETHYL ALCOHOL) GEL [KAF GRUP SAGLIK HIZMETLERI INSAAT SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 6 package rows20210108_d08c8df3-a062-443b-b4fa-77ca5c686ea4.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
81314-20181314-201-01, 81314-201-02, 81314-201-03, 81314-201-04, 81314-201-05, 81314-201-06

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
4fb64a2e-0dc9-4a06-a918-9aedcc8e8f43d08c8df3-a062-443b-b4fa-77ca5c686ea42020-12-31WarningsExact identifier
spl id: 4fb64a2e-0dc9-4a06-a918-9aedcc8e8f43
spl set id: d08c8df3-a062-443b-b4fa-77ca5c686ea4

Reported adverse events (FAERS/openFDA)#

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