Antibacterial hand and skin wet wibe

Antibacterial hand and skin wet wipe by

Drug Labeling and Warnings

Antibacterial 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]

ANTIBACTERIAL 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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Antibacterial hand and skin wet wibe

0.13% Benzalkonium Chloride (v/v)

Antiseptic

Directions

Mode of use Provides practical cleaning without using water and soap when necessary. Used for hand and skin cleaning. Open the label and take the handkerchief from it. Wipe your hands gently with an antibacterial wipe. It does not require rinsing after use.

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

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

Avoid contact with eyes, rinse eyes with running water while keeping eyelids open. If symptoms persist, seek medical attention.
After skin contact, ıf symptoms develop, seek medical attention.
After swallowing, DO NOT Vomit if swallowed. Let the victim drink plenty of water. Get medical attention immediately.
After inhalation, No expected symptoms. If symptoms develop, seek medical attention.

Stop use this product if irritation and redness develops and persists.
In case of poisoning Call the National Emergency Services immediately.

Symptoms of Poisoning are dizziness, loss of consciousness, speech disorder.

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

Other information

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

Aqua, Glycerin, Phenoxyethanol, Parfum, Polysorbate 20, Sodium PCA,Tetrasodium EDTA, Ethylhexylglycerin, Citric Acid

Used for hands and skin to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

LABEL

ANTIBACTERIAL HAND AND SKIN WET WIPE 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79781-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79781-205-01	5.1 g in 1 PACKAGE; Type 0: Not a Combination Product	07/23/2020	09/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020	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(79781-205)

Revised: 9/2022

Document Id: e9acce8a-f7d5-6258-e053-2a95a90a7f70

34390-5

Set id: a9db2b69-81fa-1adb-e053-2995a90aba0b

Version: 5

Effective Time: 20220927

 

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