FDA.reportPublic FDA data

Vitiugen Instant Hand Sanitizer

Manufacturer
PHARMEST SAGLIK URUNLERI SANAYI VE TICARET LIMITED SIRKETI | HARDAL GLOBAL CONSULTING LLC
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:12

Label at a glance#

ProductVitiugen Instant Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 60%, Isopropyl Alcohol 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

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

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 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.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Carbomer, Triethanolamine, Fragrance, Lavandula Angustifolia Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharmest

Prod. date: 04.2020

Exp. date: 04.2023

Batch No: H20008

Vitiugen Instant Hand Sanitizer

Hand Clean & Protection Gel

Rinse Free

Non Sticky

Pharmest Saglik Urunleri

San. ve Tic. Ltd. Sti.

Orhan Gazi Mah. 18. Yol Sok. No:12

Esenyurt/Istanbul TURKEY

aabbcc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2381736ethanol 60 % / isopropyl alcohol 10 % Topical GelPSN1
2381736ethanol 0.6 ML/ML / isopropyl alcohol 0.1 ML/ML Topical GelSCD1
2381736ethanol 60 % / isopropyl alcohol 10 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78984-001-102022-01-28C16284748780-1d6a99b39-c352-a426-e053-dadaa90af4c2a85f5291-ea8c-50d1-e053-2995a90ab283
78984-001-252022-01-28C16284748780-1d6a99b39-c352-a426-e053-dadaa90af4c2a85f5291-ea8c-50d1-e053-2995a90ab283
78984-001-502022-01-28C16284748780-1d6a99b39-c352-a426-e053-dadaa90af4c2a85f5291-ea8c-50d1-e053-2995a90ab283

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78984-001-10Vitiugen Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78984-001-25Vitiugen Instant Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78984-001-50Vitiugen Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78984-001VITIUGEN INSTANT HAND SANITIZER (ALCOHOL) GEL [PHARMEST SAGLIK URUNLERI SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 3 package rows20200627_a85f5291-ea8c-50d1-e053-2995a90ab283.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78984-00178984-001-50, 78984-001-10, 78984-001-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT

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
a85f5566-15c9-3d8f-e053-2a95a90adbdda85f5291-ea8c-50d1-e053-2995a90ab2832020-06-18WarningsExact identifier
spl id: a85f5566-15c9-3d8f-e053-2a95a90adbdd
spl set id: a85f5291-ea8c-50d1-e053-2995a90ab283

Reported adverse events (FAERS/openFDA)#

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