FDA.reportPublic FDA data

SIRIUS-GEL

Manufacturer
SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-07-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:20:45

Label at a glance#

ProductQuiclean
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years age should be supervised when using QUICLEAN.

Storage and handling

Store below 110 F (43C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

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.

Not edible, don't drink. Do not use in ears or mouth.

OTC - WHEN USING SECTION

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years age should be supervised when using QUICLEAN.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110 F (43C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Aminomethyl Propanol, Carbomer, Perfume (Bitter Orange oil)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 77222-222-0159 mL NDC: 77222-222-01

59 mL NDC: 77222-222-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77222-222-012021-07-23C16284748780-1c7ccaba7-1896-fd44-e053-dadaa90aa01bSIRIUS-GEL
77222-222-022021-07-23C16284748780-1c7ccaba7-1896-fd44-e053-dadaa90aa01bSIRIUS-GEL
77222-222-032021-07-23C16284748780-1c7ccaba7-1896-fd44-e053-dadaa90aa01bSIRIUS-GEL
77222-222-042021-07-23C16284748780-1c7ccaba7-1896-fd44-e053-dadaa90aa01bSIRIUS-GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77222-222-01Quiclean59 mL in 1 BOTTLEGEL593
77222-222-02Quiclean100 mL in 1 BOTTLEGEL1003
77222-222-03Quiclean250 mL in 1 BOTTLEGEL2503
77222-222-04Quiclean500 mL in 1 BOTTLEGEL5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77222-222QUICLEAN (HAND SANITIZER GEL) GEL [SIRIUS KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]3Legacy NDC, 4 package rows20200710_a4fe4a81-6c44-dc2e-e053-2995a90a616c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77222-22277222-222-01, 77222-222-02, 77222-222-03, 77222-222-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BITTER ORANGE OIL9TLV70SV6IIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
aa054e3b-6080-4bf8-e053-2995a90aa75aa4fe4a81-6c44-dc2e-e053-2995a90a616c2020-07-09WarningsExact identifier
spl id: aa054e3b-6080-4bf8-e053-2995a90aa75a
spl set id: a4fe4a81-6c44-dc2e-e053-2995a90a616c

Reported adverse events (FAERS/openFDA)#

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