FDA.reportPublic FDA data

ANTISEPTIC HAND SANITIZER

Manufacturer
NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:35

Label at a glance#

ProductANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure9 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

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

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

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,3-butandiol, glycerin, isopropyl alcohol, lanolin, fragrance, water

SPL UNCLASSIFIED SECTION

Import Company: Purple Dice LLC

+1-971-235-1506

Monday-Friday 9:00 AM - 5:00 PM

Manufactured by: NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED
SIRKETI, AYTOP GIDA SITE I BLOK, NO:14-1 B GAZI MAHALLESI SARK CADDESI GULGONCASI SOKAK,
SULTANBEYLI, Istanbul (Anatolia), Turkey 34920

COUNTRY OF ORIGIN: TURKEY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sntzr1Sntzr1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79455-001-012022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-022022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-032022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-042022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-052022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-062022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-072022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-082022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-092022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-102022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-112022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER
79455-001-122022-01-28C16284748780-1d6a99b39-abf5-a426-e053-dadaa90af4c2BiORAD DERM ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79455-001-01ANTISEPTIC HAND SANITIZER0.03 L in 1 BOTTLELIQUID0.031
79455-001-02ANTISEPTIC HAND SANITIZER0.05 L in 1 BOTTLELIQUID0.051
79455-001-03ANTISEPTIC HAND SANITIZER0.1 L in 1 BOTTLELIQUID0.11
79455-001-04ANTISEPTIC HAND SANITIZER0.25 L in 1 BOTTLELIQUID0.251
79455-001-05ANTISEPTIC HAND SANITIZER0.5 L in 1 BOTTLELIQUID0.51
79455-001-06ANTISEPTIC HAND SANITIZER0.7 L in 1 BOTTLELIQUID0.71
79455-001-07ANTISEPTIC HAND SANITIZER1 L in 1 BOTTLELIQUID11
79455-001-08ANTISEPTIC HAND SANITIZER2 L in 1 BOTTLELIQUID21
79455-001-09ANTISEPTIC HAND SANITIZER5 L in 1 CANLIQUID51
79455-001-10ANTISEPTIC HAND SANITIZER10 L in 1 CANLIQUID101
79455-001-11ANTISEPTIC HAND SANITIZER20 L in 1 DRUMLIQUID201
79455-001-12ANTISEPTIC HAND SANITIZER30 L in 1 DRUMLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79455-001ANTISEPTIC HAND SANITIZER (ALCOHOL) LIQUID [NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 12 package rows20200716_bdba6f74-9455-464d-9e75-b5b005b5c9e1.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
79455-00179455-001-01, 79455-001-02, 79455-001-03, 79455-001-04, 79455-001-05, 79455-001-06, 79455-001-07, 79455-001-08, 79455-001-09, 79455-001-10, 79455-001-11, 79455-001-12

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
ALCOHOL3K9958V90MACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
LANOLIN7EV65EAW6HIACT
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
51264530-80e9-4595-a753-5f999bb8e578bdba6f74-9455-464d-9e75-b5b005b5c9e12020-07-10WarningsExact identifier
spl id: 51264530-80e9-4595-a753-5f999bb8e578
spl set id: bdba6f74-9455-464d-9e75-b5b005b5c9e1

Reported adverse events (FAERS/openFDA)#

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