Disinfectant Hand & Skin Wet Wipe

Disinfectant Hand and Skin Wet Wipe by

Drug Labeling and Warnings

Disinfectant Hand and Skin Wet Wipe by is a Otc medication manufactured, distributed, or labeled by MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISINFECTANT HAND AND SKIN WET WIPE- benzalkonium chloride swab 
MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Disinfectant Hand & Skin Wet Wipe

ALKYLDIMETHYLBENZYLAMMONIUM CHLORIDE (w/w): 0,33%, purpose: antiseptic
ALCOHOL (w/w): 80%, purpose: antiseptic

Antiseptic

Directions

A ready to use product. On first use, open lid and remove seal label. Pull up a corner of the wipe, then carefully twist and thread it through the hole in the lid. Take as many wet wipes as you need to clean your hands and gently wipe your hands. Close the lid after use to prevent the jipes from drying out.

For use when soap and water are not available.

Kills bacteria, viruses and fungi in 2 minute.
Provides bactericidal, virucidal and fungicidal effect and protection against bacteria, viruses and fungi.
Effective against gram (+) gram (-) bacteria.
It has been shown to not cause any skin irritation.

FOR EXTERNAL USE ONLY.

KEEP AWAY FROM CHILDREN, FOOD AND ANIMAL FEEDS.
DO NOT EAT, DRINK AND SMOKE DURING THE APPLICATION AND PREPARATION.

KEEP AWAY FROM HEAT OR OPEN FLAME.

Do not use on open wounds and in children less than 2 months of age.

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

If irritation and redness develops and persist and in case of poisoning stop use and ask a doctor. Symptoms of Poisoning are dizziness, loss of consciousness and speech disorder.

IF SWALLOWED : Immediately call a POISON CENTER/ doctor.

Aqua, Coco Glucoside, Allantoin, Citric Acid

Other informations

Keep away from heat, sparks, open flames and hot surfaces. No smoking. Avoid release to the environment. Dispose of contents/ container in accordance with national regulations.

Store between 15-30 ºC. Avoid freezing and excessive heat above 40ºC

DISINFECTANT HAND AND SKIN WET WIPE 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.33 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO GLUCOSIDE (UNII: ICS790225B)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-211-01	5.1 g in 1 POUCH; Type 0: Not a Combination Product	09/01/2020
2	NDC: 79781-211-02	5.1 g in 1 POUCH; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	09/20/2020

Labeler - MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (533147775)

Establishment
Name	Address	ID/FEI	Business Operations
MOLECULE KORUYUCU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		533147775	manufacture(79781-211)

Revised: 9/2022

Document Id: e9190616-ac3b-a0ce-e053-2995a90a25d1

34390-5

Set id: ae412e4e-ffe3-4cae-e053-2995a90a556d

Version: 2

Effective Time: 20220920

 

MOLECULE KORUYUCU SAGLIK U