FDA.reportPublic FDA data

Wonvia Antibacterial Hand Disinfectant Gel

Manufacturer
KAPLAN DISTRIBUTION LLC | RKS GROUP YAPI KIMYASALLARI SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:01

Label at a glance#

ProductWonvia Antibacterial Hand Disinfectant Gel
Active ingredientISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE, ALCOHOL
Label structure12 sections

Dosage and administration

Use enough amount of solution to keep your hands wet. Rub hands together for 30 seconds. Keep away from children, food and animal feed. Follow the instruction to avoid risks to human and environmental health.

Storage and handling

Store between 15-30C (59-86F) in its original packaging upright in a cool dry place that does not receive sunlight. Avoid freezing and excessive heat above 40C (104F) Do not store more than 4 boxes in a row. Dispose of the container P501 in accordance with local regulations. Use the unpacked product within 1 month. Shelf life (25+/2°C) of the product is 2 years.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 58%, Isopropyl Alcohol 12%, Alkyl dimethyl benzyl ammonium chloride 0.2%

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Antibacterial Hand Disinfectant Gel

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • keep away from children
  • on open skin wounds
  • do not use in the cleaning of foodstuffs

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with plenty of water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not breathe directly.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Use enough amount of solution to keep your hands wet. Rub hands together for 30 seconds.
  • Keep away from children, food and animal feed.
  • Follow the instruction to avoid risks to human and environmental health.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F) in its original packaging upright in a cool dry place that does not receive sunlight.
  • Avoid freezing and excessive heat above 40C (104F)
  • Do not store more than 4 boxes in a row.
  • Dispose of the container P501 in accordance with local regulations.
  • Use the unpacked product within 1 month.
  • Shelf life (25+/2°C) of the product is 2 years.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Softener 1.5%, Resolvent 28.19%, Fragrance 0.1%, Colouring 0.01%

The Resolvent is completed with 27.8%

Proportion to 100%

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL: PRINCIPAL DISPLAY LABELPACKAGE LABEL: PRINCIPAL DISPLAY LABEL500 mL NDC: 78876-709-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2381834benzalkonium chloride 0.2 % / ethanol 58 % / isopropyl alcohol 12 % Topical GelPSN2
2381834benzalkonium chloride 0.002 MG/MG / ethanol 0.58 ML/ML / isopropyl alcohol 0.12 ML/ML Topical GelSCD2
2381834benzalkonium chloride 0.2 % / ethanol 58 % / isopropyl alcohol 12 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78876-709-052022-01-28C16284748780-1d6a99b39-928d-a426-e053-dadaa90af4c2aa17a53c-0eab-7203-e053-2995a90af2fe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78876-709-05Wonvia Antibacterial Hand Disinfectant Gel500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78876-709WONVIA ANTIBACTERIAL HAND DISINFECTANT GEL (ALCOHOL) GEL [KAPLAN DISTRIBUTION LLC]2Legacy NDC, 1 package rows20200807_aa17a53c-0eab-7203-e053-2995a90af2fe.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
78876-70978876-709-05

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
ISOPROPYL ALCOHOLND2M416302ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
ac3ccb3e-ae92-12c3-e053-2a95a90ac5d4aa17a53c-0eab-7203-e053-2995a90af2fe2020-08-06WarningsExact identifier
spl id: ac3ccb3e-ae92-12c3-e053-2a95a90ac5d4
spl set id: aa17a53c-0eab-7203-e053-2995a90af2fe

Reported adverse events (FAERS/openFDA)#

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