ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
TAT KIMYA SABUN VE GLISERIN 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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Active Ingredient(s)

Benzalkonium Chloride %0.25 w/w. Purpose : Antibacterial

Purpose

Antibacterial, Wet Wipes

Use

Antibacterial wet wipes helps reduce bacteria (organisms).

Effective on bacterias :

Staphylococcus aureus ATCC 6538,

Pseudomonas aeruginosa ATCC 15442,

Enterococcus hirae ATCC 10541,

Escherichia coli ATCC 10536

Warnings

Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Awoid contact with eyes.

Do not use

Do not use with eyes. For external use only.

In case of inhaling: If you feel uncomfortable get some fresh ait. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help. There is no specific antidote therefore treatment must be done according to symptoms. Treatment: Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER.

Treatment is indicated according to the indication. CALL YOUR LOCAL POISON CENTER

Keep out of reach of children. Children should not use this product without an adult supervision.

Directions

Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required. User group : General public

Other Information

Store in a cool and dry place.

Inactive Ingredients

Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid

Package Label - Principal Display Panel

60 Pcs. NDC : 76964-200

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76964-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C12-15 PARETH-12 (UNII: 131316X18L) 0.35 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g  in 100 g
PIROCTONE OLAMINE (UNII: A4V5C6R9FB) 0.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.25 g  in 100 g
EDETATE SODIUM (UNII: MP1J8420LU) 0.1 g  in 100 g
PANTHENOL (UNII: WV9CM0O67Z) 0.001 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 g  in 100 g
WATER (UNII: 059QF0KO0R) 98.66 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.008 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76964-200-1160 in 1 PACKAGE06/03/2020
15 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/2020
Labeler - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
Registrant - TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI (535142780)
Establishment
NameAddressID/FEIBusiness Operations
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI535142780manufacture(76964-200)

Revised: 7/2022
Document Id: e43b6212-edcc-35bf-e053-2995a90a0ab1
Set id: a751ec8b-82f3-41b3-e053-2995a90a4777
Version: 4
Effective Time: 20220720
 
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI