KONIX by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS KONIX- alcohol solution

KONIX by

Drug Labeling and Warnings

KONIX by is a Otc medication manufactured, distributed, or labeled by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Rub

Use

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

Warnings

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

Do not use

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

WHEN USING

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.

STOP USE

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

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

Directions

• 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

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Alcohol Antiseptic 80%Topical SolutionAntiseptic Hand RubNon-sterile Solution

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

KONIX 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73107-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73107-102-33	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
2	NDC: 73107-102-34	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
3	NDC: 73107-102-35	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
4	NDC: 73107-102-36	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
5	NDC: 73107-102-37	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
6	NDC: 73107-102-38	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
7	NDC: 73107-102-39	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
8	NDC: 73107-102-32	85 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
9	NDC: 73107-102-31	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
10	NDC: 73107-102-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2020
11	NDC: 73107-102-40	5 mL in 1 PACKET; Type 0: Not a Combination Product	04/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/07/2020

Labeler - Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS (356325295)

Establishment
Name	Address	ID/FEI	Business Operations
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS		356325295	manufacture(73107-102)