FDA.reportPublic FDA data

dr.Clinic ® ANTIBACTERIAL HAND GEL

Manufacturer
MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:23:12

Label at a glance#

ProductDR.CLINIC ANTIBACTERIAL HAND SANITIZER
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 73%

Purpose

OTC - PURPOSE SECTION

Antibacterial

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 ingredients

INACTIVE INGREDIENT SECTION

carbomer, glycerin, triethanolamine, water

Question? +1-XXX-XXX-XXXX

OTC - QUESTIONS SECTION

You may also report serious side effects to this number.

Mon-Fri 9.00 AM - 5.00 PM

SPL UNCLASSIFIED SECTION

MADE IN TURKEY

Name and address of the owner of the manufacturer

/ Name and address of the license holder:

MAKYAJ KOZMETIK IN‑AAT SANAYI TICARET LIMITED ‑IRKETI

Hadımköy Baglantı Yolu Akçaburgaz Mah. Esenyurt / Istanbul

info@makyajkozmetik.com.tr

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286987ethanol 73 % Topical GelPSN5
2286987ethanol 0.73 ML/ML Topical GelSCD5
2286987ethanol 73 % Topical GelSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76725-101-012022-01-28C16284748780-1d6a99b39-445e-a426-e053-dadaa90af4c2dr.Clinic ® ANTIBACTERIAL HAND GEL
76725-101-032022-01-28C16284748780-1d6a99b39-445e-a426-e053-dadaa90af4c2dr.Clinic ® ANTIBACTERIAL HAND GEL
76725-101-042022-01-28C16284748780-1d6a99b39-445e-a426-e053-dadaa90af4c2dr.Clinic ® ANTIBACTERIAL HAND GEL
76725-101-052022-01-28C16284748780-1d6a99b39-445e-a426-e053-dadaa90af4c2dr.Clinic ® ANTIBACTERIAL HAND GEL
76725-101-062022-01-28C16284748780-1d6a99b39-445e-a426-e053-dadaa90af4c2dr.Clinic ® ANTIBACTERIAL HAND GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76725-101-01DR.CLINIC ANTIBACTERIAL HAND SANITIZER100 mL in 1 BOTTLEGEL1005
76725-101-03DR.CLINIC ANTIBACTERIAL HAND SANITIZER500 mL in 1 BOTTLEGEL5005
76725-101-04DR.CLINIC ANTIBACTERIAL HAND SANITIZER1000 mL in 1 BOTTLEGEL10005
76725-101-05DR.CLINIC ANTIBACTERIAL HAND SANITIZER5000 mL in 1 CANGEL50005
76725-101-06DR.CLINIC ANTIBACTERIAL HAND SANITIZER250 mL in 1 BOTTLEGEL2505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76725-101DR.CLINIC ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) GEL [MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI]5Legacy NDC, 5 package rows20200731_00deac3a-80b8-4b47-98ed-0b401b5cfc0f.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
76725-10176725-101-01, 76725-101-06, 76725-101-03, 76725-101-04, 76725-101-05

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 · 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
46c03834-c4d2-4032-823b-e4d93da7dbcf00deac3a-80b8-4b47-98ed-0b401b5cfc0f2020-07-30WarningsExact identifier
spl id: 46c03834-c4d2-4032-823b-e4d93da7dbcf
spl set id: 00deac3a-80b8-4b47-98ed-0b401b5cfc0f

Reported adverse events (FAERS/openFDA)#

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