FDA.reportPublic FDA data

FRONTLINE HAND SANITIZER - Antibacterial

Manufacturer
DINAMO KOZMETIK VE TEKSTIL DIS TICARET ANONIM SIRKETI
Effective date
2020-08-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:58

Label at a glance#

ProductFRONTLINE HAND SANITIZER - Antibacterial
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Apply to hands thoroughly with product and rub into skin 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 ingredeint[s]

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use[s]:

INDICATIONS & USAGE SECTION

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: on hands. Flammable.

Keep away from heat or flame. Do not use

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

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.

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

  • Apply to hands thoroughly with product and rub into skin 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

Water, Glycerin, Carbomer, Fragrance, Triethanolamine

SPL UNCLASSIFIED SECTION

% 70 Alcohol

Kills 99.9% of bacteria WITHOUT WATER

Fast Drying

Non Sticky

MADE IN TURKEY

Distributed by: Sinerji Trade Ltd.

+90 212 850 8888

www.sinerji.com.tr

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79853-100-032022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-052022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-102022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-112022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-202022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-252022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-502022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-512022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-552022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial
79853-100-702022-01-28C16284748780-1d6a99b39-f934-a426-e053-dadaa90af4c2FRONTLINE HAND SANITIZER - Antibacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79853-100-03FRONTLINE HAND SANITIZER - Antibacterial3 mL in 1 POUCHGEL31
79853-100-05FRONTLINE HAND SANITIZER - Antibacterial5 mL in 1 POUCHGEL51
79853-100-10FRONTLINE HAND SANITIZER - Antibacterial100 mL in 1 BOTTLE, PLASTICGEL1001
79853-100-11FRONTLINE HAND SANITIZER - Antibacterial1000 mL in 1 BOTTLE, PLASTICGEL10001
79853-100-20FRONTLINE HAND SANITIZER - Antibacterial200 mL in 1 BOTTLE, PLASTICGEL2001
79853-100-25FRONTLINE HAND SANITIZER - Antibacterial250 mL in 1 BOTTLE, PLASTICGEL2501
79853-100-50FRONTLINE HAND SANITIZER - Antibacterial50 mL in 1 BOTTLE, PLASTICGEL501
79853-100-51FRONTLINE HAND SANITIZER - Antibacterial5000 mL in 1 BOTTLE, PLASTICGEL50001
79853-100-55FRONTLINE HAND SANITIZER - Antibacterial500 mL in 1 BOTTLE, PLASTICGEL5001
79853-100-70FRONTLINE HAND SANITIZER - Antibacterial70 mL in 1 BOTTLE, PLASTICGEL701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79853-100FRONTLINE HAND SANITIZER - ANTIBACTERIAL (ETHYL ALCOHOL) GEL [DINAMO KOZMETIK VE TEKSTIL DIS TICARET ANONIM SIRKETI]1Legacy NDC, 10 package rows20200807_634f6c5b-85b9-4ac5-8d1e-a3260e8504fa.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
79853-10079853-100-03, 79853-100-05, 79853-100-50, 79853-100-70, 79853-100-10, 79853-100-20, 79853-100-25, 79853-100-55, 79853-100-11, 79853-100-51

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
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
20b38a48-afca-4c00-8868-6512dea2ecba634f6c5b-85b9-4ac5-8d1e-a3260e8504fa2020-08-03WarningsExact identifier
spl id: 20b38a48-afca-4c00-8868-6512dea2ecba
spl set id: 634f6c5b-85b9-4ac5-8d1e-a3260e8504fa

Reported adverse events (FAERS/openFDA)#

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