FDA.reportPublic FDA data

MediLive

Manufacturer
Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:14

Label at a glance#

ProductMediLive
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• Hand Sanitizer to decrease bacteria on the skin • Recommended for repeated use • For use when soap and water are not available

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping Supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

Do not store in direct sunlight Store below 50°C / 105°F Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Hand Sanitizer to decrease bacteria on the skin • Recommended for repeated use • For use when soap and water are not available

WARNINGS

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

Do not use

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

Stop use and ask a doctor if

  • irritation and redness develop
  • 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

  • Wet hands thoroughly with product and allow to dry without wiping
  • Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

STORAGE AND HANDLING SECTION

  • Do not store in direct sunlight
  • Store below 50°C / 105°F
  • Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, glycerin, carbomer, triethanolamine, parfum, tocopheryl acetate, aloe barbadensis leaf juice, benzylsalicylate, linalool, limonene, hydroxycitronellal, coumarin.

OTC - QUESTIONS SECTION

Questions : export@endekskimya.com

Mon - Fri 9:00 AM - 5:00 PM You may also report serious side effects to this phone number

SPL UNCLASSIFIED SECTION

No rinsing

%70 ALCOHOL

Uretici / Manufacturer

Ishlab chiqaruvchi /

endeks

Kimya San. ve Tic A.S.

Adnan Kahveci Mahallesi, Davutpasa Cad.No:17

Beylikdüzü / ISTANBUL Tel: +90 212 856 13 66

info@endekskimya.com export@endekskimya.com

Icerik veri belgesinin edinilebilecegi adres:

www.endekskmya.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78089-026-012022-01-28C16284748780-1d6a99b39-c1b9-a426-e053-dadaa90af4c2MediLive Antiseptic Hand Sanitizer
78089-026-022022-01-28C16284748780-1d6a99b39-c1b9-a426-e053-dadaa90af4c2MediLive Antiseptic Hand Sanitizer
78089-026-032022-01-28C16284748780-1d6a99b39-c1b9-a426-e053-dadaa90af4c2MediLive Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78089-026-01MediLive100 mL in 1 BOTTLEGEL1001
78089-026-02MediLive236 mL in 1 BOTTLEGEL2361
78089-026-03MediLive500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78089-026MEDILIVE (ETHYL ALCOHOL) GEL [ENDEKS KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 3 package rows20200606_0ceee9c5-400e-4c54-9c43-aa281fa1a290.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78089-02678089-026-01, 78089-026-02, 78089-026-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+)-GFD7C86Q1WIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
COUMARINA4VZ22K1WTIACT

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
6c45018e-2efb-48ff-af9c-39037fe78ee10ceee9c5-400e-4c54-9c43-aa281fa1a2902020-06-02WarningsExact identifier
spl id: 6c45018e-2efb-48ff-af9c-39037fe78ee1
spl set id: 0ceee9c5-400e-4c54-9c43-aa281fa1a290

Reported adverse events (FAERS/openFDA)#

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