ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WHEN USING

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.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76964-200
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76964-200-11	60 in 1 PACKAGE	06/03/2020
1		5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/03/2020

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
Name	Address	ID/FEI	Business Operations
TAT KIMYA SABUN VE GLISERIN SANAYI VE TICARET ANONIM SIRKETI		535142780	manufacture(76964-200)