FDA.reportPublic FDA data

Sirenol Antiseptic Topical Solution

Manufacturer
BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2020-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:58

Label at a glance#

ProductSirenol Antiseptic Topical
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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

  • 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,rines eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poision Control Center right away.

Other Information (if applicable) :

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C0 (104F0)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Glycerin, Aloe Barbadensis Leaf Extract, Purified Water USP.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80441-001-012022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-022022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-032022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-042022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-052022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-062022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-072022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-082022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-092022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-102022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-112022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-122022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-132022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-142022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-152022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-162022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-172022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-182022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution
80441-001-192022-07-29C16284748780-1e4f33bdf-a038-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80441-001-01Sirenol Antiseptic Topical6 in 1 PACKAGESOLUTION61
80441-001-01Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-02Sirenol Antiseptic Topical10 in 1 PACKAGESOLUTION101
80441-001-02Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-03Sirenol Antiseptic Topical20 in 1 PACKAGESOLUTION201
80441-001-03Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-04Sirenol Antiseptic Topical100 in 1 PACKAGESOLUTION1001
80441-001-04Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-05Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-05Sirenol Antiseptic Topical1000 in 1 PACKAGESOLUTION10001
80441-001-06Sirenol Antiseptic Topical60 in 1 BOTTLESOLUTION601
80441-001-06Sirenol Antiseptic Topical150 mL in 1 NOT APPLICABLESOLUTION1501
80441-001-07Sirenol Antiseptic Topical80 in 1 BOTTLESOLUTION801
80441-001-07Sirenol Antiseptic Topical200 mL in 1 NOT APPLICABLESOLUTION2001
80441-001-08Sirenol Antiseptic Topical250 mL in 1 NOT APPLICABLESOLUTION2501
80441-001-08Sirenol Antiseptic Topical100 in 1 BOTTLESOLUTION1001
80441-001-09Sirenol Antiseptic Topical25 mL in 1 BOTTLESOLUTION251
80441-001-10Sirenol Antiseptic Topical50 mL in 1 BOTTLESOLUTION501
80441-001-11Sirenol Antiseptic Topical100 mL in 1 BOTTLESOLUTION1001
80441-001-12Sirenol Antiseptic Topical150 mL in 1 BOTTLESOLUTION1501
80441-001-13Sirenol Antiseptic Topical200 mL in 1 BOTTLESOLUTION2001
80441-001-14Sirenol Antiseptic Topical250 mL in 1 BOTTLESOLUTION2501
80441-001-15Sirenol Antiseptic Topical500 mL in 1 BOTTLESOLUTION5001
80441-001-16Sirenol Antiseptic Topical1000 mL in 1 BOTTLESOLUTION10001
80441-001-17Sirenol Antiseptic Topical3785 mL in 1 BOTTLESOLUTION37851
80441-001-18Sirenol Antiseptic Topical5000 mL in 1 BOTTLESOLUTION50001
80441-001-19Sirenol Antiseptic Topical10000 mL in 1 BOTTLESOLUTION100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80441-001SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) SOLUTION [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI]1Legacy NDC, 27 package rows20200910_f26854eb-eec7-477c-9dbf-c13eb089bfa3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80441-00180441-001-01, 80441-001-02, 80441-001-03, 80441-001-04, 80441-001-05, 80441-001-06, 80441-001-07, 80441-001-08, 80441-001-09, 80441-001-10, 80441-001-11, 80441-001-12, 80441-001-13, 80441-001-14, 80441-001-15, 80441-001-16, 80441-001-17, 80441-001-18, 80441-001-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
b10bfd21-0eea-4784-81e0-505a9a8ae270f26854eb-eec7-477c-9dbf-c13eb089bfa32020-09-02WarningsExact identifier
spl id: b10bfd21-0eea-4784-81e0-505a9a8ae270
spl set id: f26854eb-eec7-477c-9dbf-c13eb089bfa3