FDA.reportPublic FDA data

Sirenol Antiseptic Topical Gel

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, Carbomer homopolymer, unspecified type

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80441-002-012022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-022022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-032022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-042022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-052022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-062022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-072022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-082022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-092022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-102022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-112022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-122022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-132022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-142022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-152022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel
80441-002-162022-07-29C16284748780-1e4f33bdf-9ca2-d8a0-e053-dadaa90a6e4eSirenol Antiseptic Topical Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80441-002-01Sirenol Antiseptic Topical25 mL in 1 BOTTLEGEL251
80441-002-02Sirenol Antiseptic Topical50 mL in 1 BOTTLEGEL501
80441-002-03Sirenol Antiseptic Topical100 mL in 1 BOTTLEGEL1001
80441-002-04Sirenol Antiseptic Topical150 mL in 1 BOTTLEGEL1501
80441-002-05Sirenol Antiseptic Topical200 mL in 1 BOTTLEGEL2001
80441-002-06Sirenol Antiseptic Topical250 mL in 1 BOTTLEGEL2501
80441-002-07Sirenol Antiseptic Topical500 mL in 1 BOTTLEGEL5001
80441-002-08Sirenol Antiseptic Topical1000 mL in 1 BOTTLEGEL10001
80441-002-09Sirenol Antiseptic Topical3785 mL in 1 BOTTLEGEL37851
80441-002-10Sirenol Antiseptic Topical5000 mL in 1 BOTTLEGEL50001
80441-002-11Sirenol Antiseptic Topical10000 mL in 1 BOTTLEGEL100001
80441-002-12Sirenol Antiseptic Topical6 in 1 PACKAGEGEL61
80441-002-12Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLEGEL51
80441-002-13Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLEGEL51
80441-002-13Sirenol Antiseptic Topical10 in 1 PACKAGEGEL101
80441-002-14Sirenol Antiseptic Topical20 in 1 PACKAGEGEL201
80441-002-14Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLEGEL51
80441-002-15Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLEGEL51
80441-002-15Sirenol Antiseptic Topical100 in 1 PACKAGEGEL1001
80441-002-16Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLEGEL51
80441-002-16Sirenol Antiseptic Topical1000 in 1 PACKAGEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80441-002SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) GEL [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI]1Legacy NDC, 21 package rows20200910_f26bfa16-3c9e-45ef-8156-988095b869f6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80441-00280441-002-01, 80441-002-02, 80441-002-03, 80441-002-04, 80441-002-05, 80441-002-06, 80441-002-07, 80441-002-08, 80441-002-09, 80441-002-10, 80441-002-11, 80441-002-12, 80441-002-13, 80441-002-14, 80441-002-15, 80441-002-16

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
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
b0a5f86d-ccad-4f88-ab36-ed3013aa5859f26bfa16-3c9e-45ef-8156-988095b869f62020-09-02WarningsExact identifier
spl id: b0a5f86d-ccad-4f88-ab36-ed3013aa5859
spl set id: f26bfa16-3c9e-45ef-8156-988095b869f6

Reported adverse events (FAERS/openFDA)#

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