FDA.reportPublic FDA data

Vitiugen Anti Bacterial Sprey

Manufacturer
PHARMEST SAGLIK URUNLERI SANAYI VE TICARET LIMITED SIRKETI | HARDAL GLOBAL CONSULTING LLC
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:13

Label at a glance#

ProductVitiugen Anti Bacterial Sprey
Active ingredientALCOHOL
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 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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

Butan, Isobutan, Propan, Glycerin, Aloe Barbadensis Leaf Extract, Vitamin E

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitiugen

Anti Bacterial Sprey

Hygenic-Surgical

Alcohol Based

Hand and Skin Antiseptic

It kills 99.9% of the tested bacteria.

It kills the tested bacteria in 1 minute.

It provides antibacterial protection against tested bacteria.

It is formulated in the pH range compatible with the skin.

Pharmest Saglik Urunleri San. ve Tic. Ltd. Sti.

Orhan Gazi Mah. 18. Yol Sok. No: 12 Esenyurt/Istanbul TURKEY

SpreySprey

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN1
1241663ethanol 0.8 ML/ML Topical SpraySCD1
1241663ethanol 80 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78984-002-152022-01-28C16284748780-1d6a99b39-f610-a426-e053-dadaa90af4c2a8b01bbe-864e-c34c-e053-2995a90a48ca

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78984-002-15Vitiugen Anti Bacterial Sprey150 mL in 1 BOTTLE, SPRAYSPRAY1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78984-002VITIUGEN ANTI BACTERIAL SPREY (ALCOHOL) SPRAY [PHARMEST SAGLIK URUNLERI SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 1 package rows20200627_a8b01bbe-864e-c34c-e053-2995a90a48ca.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
78984-00278984-002-15

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
BUTANE6LV4FOR43RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOBUTANEBXR49TP611IACT
PROPANET75W9911L6IACT

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
a8b01b1c-19c5-1fe6-e053-2a95a90ac16da8b01bbe-864e-c34c-e053-2995a90a48ca2020-06-22WarningsExact identifier
spl id: a8b01b1c-19c5-1fe6-e053-2a95a90ac16d
spl set id: a8b01bbe-864e-c34c-e053-2995a90a48ca

Reported adverse events (FAERS/openFDA)#

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