KONIX

Manufacturer
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS
Effective date
2020-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:23

Label at a glance#

ProductKONIX
Active ingredientALCOHOL
Label structure23 sections

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand rub is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Rub

Use

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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

  • 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.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Alcohol Antiseptic 80%Topical SolutionAntiseptic Hand RubNon-sterile Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 ml 0.17fl.OZ NDC: 73107-102-40

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml 1fl.OZ NDC: 73107-102-30

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 ml 1.7fl.OZ NDC: 73107-102-31

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85 ml 2.8fl.OZ NDC: 73107-102-32

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 ml 3.4fl.OZ NDC: 73107-102-33

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 ml 5fl.OZ NDC: 73107-102-34

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 ml 6.7fl.OZ NDC: 73107-102-35

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 ml 8.5fl.OZ NDC: 73107-102-36

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml 16.9fl.OZ NDC: 73107-102-37

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ml 33.8fl.OZ NDC: 73107-102-36

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5000 ml 169fl.OZ NDC: 73107-102-39

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73107-102-30KONIX30 mL in 1 BOTTLESOLUTION301
73107-102-31KONIX50 mL in 1 BOTTLESOLUTION501
73107-102-32KONIX85 mL in 1 BOTTLESOLUTION851
73107-102-33KONIX100 mL in 1 BOTTLESOLUTION1001
73107-102-34KONIX150 mL in 1 BOTTLESOLUTION1501
73107-102-35KONIX200 mL in 1 BOTTLESOLUTION2001
73107-102-36KONIX250 mL in 1 BOTTLESOLUTION2501
73107-102-37KONIX500 mL in 1 BOTTLESOLUTION5001
73107-102-38KONIX1000 mL in 1 BOTTLESOLUTION10001
73107-102-39KONIX5000 mL in 1 BOTTLESOLUTION50001
73107-102-40KONIX5 mL in 1 PACKETSOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73107-102KONIX (ALCOHOL) SOLUTION [TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TIC. AS]1Legacy NDC, 11 package rows20200415_bea72f99-4824-45a2-972f-01e194e91c9e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
c71adb79-1f4e-45d9-be30-7e276e5950c2bea72f99-4824-45a2-972f-01e194e91c9e2020-04-05WarningsExact identifier
spl id: c71adb79-1f4e-45d9-be30-7e276e5950c2
spl set id: bea72f99-4824-45a2-972f-01e194e91c9e

Reported adverse events (FAERS/openFDA)#

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