Bittol Anti-Bacterial Wet Wipes

Bittol Anti-Bacterial Wet Wipes by

Drug Labeling and Warnings

Bittol Anti-Bacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BITTOL ANTI-BACTERIAL WET WIPES- benzalkonium chloride cloth 
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi

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Bittol Anti-Bacterial Wet Wipes

Drug Facts

Active Ingredient (by volume)

Benzalkonium Chloride % 0.13

Purpose

Antibacterial

Uses

• decreases bacteria on skin.

WARNINGS

For external use only

Do not use:

Over large areas of the body if you are allergic to any of the ingredients.

When using this product

do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor 

if irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children.

For children under 2 years ask a doctor before use. For children use under adult supervision.

Directions

Removelid and open the seal. Pull up the corner of the center sheet, twist and thread through the dispenser split in the lid. Pull sheet out at an angle. When finished close lid flap to retain moisture.

Other Information:

Do not expose to direct sunlight, preferably place them in a cool place. Do not use on furniture. Do not flush down toilets, dispose in trash can.

Inactive Ingredients:

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

Package Labeling:10 Count

Package Labeling:40 Count

Package Labeling:72 Count

Package Labeling:100 Count

Package Labeling:120 Count

BITTOL ANTI-BACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78564-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78564-000-01	10 in 1 PACKET	07/10/2020	10/31/2022
1		3.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 78564-000-02	40 in 1 PACKET	07/10/2020	10/31/2022
2		3.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 78564-000-03	72 in 1 PACKET	07/10/2020	10/31/2022
3		3.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 78564-000-04	100 in 1 PACKET	07/10/2020	10/31/2022
4		3.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5	NDC: 78564-000-05	120 in 1 PACKET	07/10/2020	10/31/2022
5		3.1 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/10/2020	10/31/2022

Labeler - Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi (565657236)

Revised: 5/2024

Document Id: 19c34213-51e2-79a8-e063-6394a90a92bd

34390-5

Set id: 24d91fdf-3b2e-4c9c-b0a8-c6f593476e0e

Version: 4

Effective Time: 20240531

 

Taha Kimya Kozmetik Ve Tuketim U