FDA.reportPublic FDA data

Instant Hand Sanitizer Gel

Manufacturer
MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:53

Label at a glance#

ProductInstant Hand Sanitizer Gel
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

do not store in direct sunlight store below 50°C /105°F avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

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

  • do not store in direct sunlight
  • store below 50°C /105°F
  • avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carbomer, glycerin, triethanolamine, water

OTC - QUESTIONS SECTION

Questions? +1-917-471-1271
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

■ Antiseptic

■ Non Sticky

■ Scent Free

Distributed By

FRESH N CLEAR LLC

1 Passaic Ave Unit 6

Wood-Ridge, NJ, 07075

PRODUCT OF TURKEY

Email: info@freshnclear.com

nqa ISO 22718 Registered Quality Management

nqa ISO 9001 Registered Quality Management

U K A S MANAGEMENT SYSTEMS

N-114992/1              CE

N-114992

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77550-101-502022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-512022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-522022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-532022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-542022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-552022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-562022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-572022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-582022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-592022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-602022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-612022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-622022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL
77550-101-632022-01-28C16284748780-1d6a99b39-a8cc-a426-e053-dadaa90af4c2DEVANOV ® ​ANTISEPTIC HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77550-101-50Instant Hand Sanitizer Gel50 mL in 1 BOTTLEGEL501
77550-101-51Instant Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1001
77550-101-52Instant Hand Sanitizer Gel200 mL in 1 BOTTLEGEL2001
77550-101-53Instant Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2501
77550-101-54Instant Hand Sanitizer Gel400 mL in 1 BOTTLEGEL4001
77550-101-55Instant Hand Sanitizer Gel500 mL in 1 BOTTLEGEL5001
77550-101-56Instant Hand Sanitizer Gel1000 mL in 1 BOTTLEGEL10001
77550-101-57Instant Hand Sanitizer Gel2000 mL in 1 BOTTLEGEL20001
77550-101-58Instant Hand Sanitizer Gel4000 mL in 1 BOTTLEGEL40001
77550-101-59Instant Hand Sanitizer Gel5000 mL in 1 BOTTLEGEL50001
77550-101-60Instant Hand Sanitizer Gel10000 mL in 1 CONTAINERGEL100001
77550-101-60Instant Hand Sanitizer Gel1 in 1 BOXGEL11
77550-101-61Instant Hand Sanitizer Gel1 in 1 BOXGEL11
77550-101-61Instant Hand Sanitizer Gel20000 mL in 1 CONTAINERGEL200001
77550-101-62Instant Hand Sanitizer Gel1 in 1 BOXGEL11
77550-101-62Instant Hand Sanitizer Gel25000 mL in 1 CONTAINERGEL250001
77550-101-63Instant Hand Sanitizer Gel30000 mL in 1 CONTAINERGEL300001
77550-101-63Instant Hand Sanitizer Gel1 in 1 BOXGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77550-101INSTANT HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [MAQAS GROUP GAYRIMENKUL TURIZM SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 18 package rows20200604_a353dc32-4a83-4c2e-8759-2be06c3d0eab.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
77550-10177550-101-50, 77550-101-51, 77550-101-52, 77550-101-53, 77550-101-54, 77550-101-55, 77550-101-56, 77550-101-57, 77550-101-58, 77550-101-59, 77550-101-60, 77550-101-61, 77550-101-62, 77550-101-63

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
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
707f9a5f-cfbb-434d-baf2-b5a3c24adbf6a353dc32-4a83-4c2e-8759-2be06c3d0eab2020-05-19WarningsExact identifier
spl id: 707f9a5f-cfbb-434d-baf2-b5a3c24adbf6
spl set id: a353dc32-4a83-4c2e-8759-2be06c3d0eab

Reported adverse events (FAERS/openFDA)#

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