FDA.reportPublic FDA data

Smart ANTISEPTIC HAND SANITIZER

Manufacturer
OZDEN KIMYA VE PLASTIK SANAYI TICARET ANONIM SIRKETI
Effective date
2020-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:02

Label at a glance#

ProductSmart ANTISEPTIC HAND SANITIZER
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

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 71% v/v

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

Flammable, keep away from fire/flame

For external use only

Do not use

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

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

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

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, carbomer, glycerin, water

Questions?

OTC - QUESTIONS SECTION

+1-718- 427- 5651

You may also report serious side effects to this phone number. 

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Manufactured for:

OZDEN KIMYA ve Plastik San. Tic. A.S.

Saray Mah. 191 Cad. No:4, Kazan, Ankara, TURKEY, 06980

COUNTRY OF ORIGIN: TURKEY

Tel: +90.312 815 50 14  www.ozdengroup.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2282911ethanol 71 % Topical GelPSN1
2282911ethanol 0.71 ML/ML Topical GelSCD1
2282911ethanol 71 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78826-100-502022-01-28C16284748780-1d6a99b39-5c6b-a426-e053-dadaa90af4c2Smart ® ANTISEPTIC HAND SANITIZER
78826-100-512022-01-28C16284748780-1d6a99b39-5c6b-a426-e053-dadaa90af4c2Smart ® ANTISEPTIC HAND SANITIZER
78826-100-522022-01-28C16284748780-1d6a99b39-5c6b-a426-e053-dadaa90af4c2Smart ® ANTISEPTIC HAND SANITIZER
78826-100-532022-01-28C16284748780-1d6a99b39-5c6b-a426-e053-dadaa90af4c2Smart ® ANTISEPTIC HAND SANITIZER
78826-100-542022-01-28C16284748780-1d6a99b39-5c6b-a426-e053-dadaa90af4c2Smart ® ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78826-100-50Smart ANTISEPTIC HAND SANITIZER50 mL in 1 BOTTLEGEL501
78826-100-51Smart ANTISEPTIC HAND SANITIZER100 mL in 1 BOTTLEGEL1001
78826-100-52Smart ANTISEPTIC HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78826-100-53Smart ANTISEPTIC HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78826-100-54Smart ANTISEPTIC HAND SANITIZER1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78826-100SMART ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [OZDEN KIMYA VE PLASTIK SANAYI TICARET ANONIM SIRKETI]1Legacy NDC, 5 package rows20200704_64eb1523-c746-4010-b55f-e43faa756617.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78826-10078826-100-50, 78826-100-51, 78826-100-52, 78826-100-53, 78826-100-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
c7637425-e9d7-4334-aa62-0624d852508e64eb1523-c746-4010-b55f-e43faa7566172020-06-28WarningsExact identifier
spl id: c7637425-e9d7-4334-aa62-0624d852508e
spl set id: 64eb1523-c746-4010-b55f-e43faa756617

Reported adverse events (FAERS/openFDA)#

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