FDA.reportPublic FDA data

WANCARE

Manufacturer
KAF GRUP SAGLIK HIZMETLERI INSAAT SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:39

Label at a glance#

ProductWANCARE ONEHAND HAND SANITIZER
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, Fragrance 

SPL UNCLASSIFIED SECTION

70% ALCOHOL

Topical Solution

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
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81314-101-012024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER
81314-101-022024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER
81314-101-032024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER
81314-101-042024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER
81314-101-052024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER
81314-101-062024-01-30C16284748780-11030e365-35f2-111a-e063-dadaa90a10e2WANCARE ONEHAND HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81314-101-01WANCAREONEHAND HAND SANITIZER50 mL in 1 BOTTLESOLUTION501
81314-101-02WANCAREONEHAND HAND SANITIZER100 mL in 1 BOTTLESOLUTION1001
81314-101-03WANCAREONEHAND HAND SANITIZER250 mL in 1 BOTTLESOLUTION2501
81314-101-04WANCAREONEHAND HAND SANITIZER500 mL in 1 BOTTLESOLUTION5001
81314-101-05WANCAREONEHAND HAND SANITIZER1000 mL in 1 BOTTLESOLUTION10001
81314-101-06WANCAREONEHAND HAND SANITIZER5000 mL in 1 BOTTLESOLUTION50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81314-101WANCARE ONEHAND HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [KAF GRUP SAGLIK HIZMETLERI INSAAT SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 6 package rows20210108_cd7b4f7b-b28f-47e4-8ae1-5783b6847e8b.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81314-10181314-101-01, 81314-101-02, 81314-101-03, 81314-101-04, 81314-101-05, 81314-101-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
6f60dd1c-c354-4181-a341-883647d4eb2ccd7b4f7b-b28f-47e4-8ae1-5783b6847e8b2020-12-30WarningsExact identifier
spl id: 6f60dd1c-c354-4181-a341-883647d4eb2c
spl set id: cd7b4f7b-b28f-47e4-8ae1-5783b6847e8b

Reported adverse events (FAERS/openFDA)#

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