KLERAX by ASEF ISLAK MENDIL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI ANTIBACTERIAL WET WIPES

KLERAX by

Drug Labeling and Warnings

KLERAX by is a Otc medication manufactured, distributed, or labeled by ASEF ISLAK MENDIL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KLERAX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
ASEF ISLAK MENDIL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI

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ANTIBACTERIAL WET WIPES

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.23%

Purpose

Antibacterial

Use:

To decrease bacteria on the skin

Warnings

For external use only

Do not use if you are allergic to any of the product's ingredients.

When using this product keep it out of eyes. If it contacts eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Directions

Open the lid, remove the band and pull out the wipe. After use, reseal the band and close the lid to maintain wetness.

Adult and children 2 years and over: apply to hands.

  Children under 2 years: ask a doctor before use.

Do NOT flush wipes, trash only.

Other information

Store at room temperature and protect from sun exposure.

Production date, expiration date and lot number are printed on the package.

Inactive ingredients

Aqua(97.17%), Emulsifier (0.3%), Moisturizer (0.2%), Preservative (0.8%), Parfum (0.3%), Skin Conditioner (0.68%), Tetrasodium EDTA (0.1%)

Kills 99.9% of Bacteria*

Maximum PROTECTION

√ Alcohol Free

√ pH Balanced

DERMATOLOGICALLY TESTED

Hygienically clean!

The product is effective against harmful organisms:

MICROORGANISMS WHICH THE              PRODUCT IS EFFECTIVE	USAGE	DOSE/RANGE OF USE
		WHEN NEEDED
Stapyhlococcus aureus ATCC 6538  Pseudomonas Aeruginosa ATCC 15442  Enterococcus hirae ATCC 10541  Escerichia coli ATCC 10536  C. albican ATCC 10231  Aspergillus brasiliensis ATCC 16404	Antibacterial Wet Wipes It is  used as wiping in the  cleaning of bacteria in the  hands. No rinsing is required.	The number of wet  wipes used to wipe the  hands, arms and  desired area is 1.

Provides practical cleaning without the need of water and soap. It is used for hand cleaning. Open the label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required. Commercial name of the product: Antibacterial Wet Wipes Formulation Form: Solid(Absorbed solution in fabric) Fabric structure: Nonwoven fabric. Active material name and amount: %50 cons, quaternary ammonium compounds, benziyl(C12-16) alkyl dimethyl, chlorides(Cas No:68242-85-1) solution was used at 0.46% cons. Warnings: Under normal conditions, its shelf life is 2 years. Use the opened product within 3 months. Keep out of reach of children and store in a cool dry place. Avoid direct sunlight and eye contact. Amounts of active ingredient absorbed in wipe are given in the table.

*Kills 99.9% of Stapyhlococcus aureus ATCC 6538, Pseudomonas Aeruginosa ATCC 15442, Enterococcus hirae ATCC 10541, Escerichia coli ATCC 10536.

Producer under hygienic environment and conditions according to GMP-ISO 22716 and ISO 9001:2015 Quality Management System.

Manufacturer

ASEF Islak Mendil Kozmetik San. ve Tic. Ltd. Sti.

Osmangazi Mah. 3125. Sk.

No:10/5 Esenyurt / Istanbul

Tel: +90 (0212) 886 65 73

www.asefkozmetik.com.tr

info@asefkozmetik.com.tr

Made in Turkey

Packaging

KLERAX  ANTIBACTERIAL WET WIPES
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81491-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.23 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERYL OLEATE (UNII: 4PC054V79P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81491-101-01	80 in 1 PACKET	02/16/2021	12/31/2022
1		3.078 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	02/16/2021	12/31/2022

Labeler - ASEF ISLAK MENDIL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI (533150916)

Establishment
Name	Address	ID/FEI	Business Operations
ASEF ISLAK MENDIL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI		533150916	manufacture(81491-101)

Revised: 10/2023

Document Id: ac814710-a574-4f6e-9f7b-d5c96557e7b6

34390-5

Set id: 476d1a08-5825-4a4b-9538-d4af8b65c1de

Version: 2

Effective Time: 20231010

 

ASEF ISLAK MENDIL KO