DEEP FRESH ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

DEEP FRESH ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

DEEP FRESH ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. BENZALKONIUM CHLORIDE (0.23%, weight/weight (w/w)
2. Dehydroacetic Acid
3. Benzoic Acid
4. Lauryl Glucoside
5. Glycerin
6. Propylene Glycol
7. Etidronate Tetrasodium
8. Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester
9. Fatty-Acid Amide Hydrolase 1
10. Phenoxyethanol
11. Dicaprylyl Carbonate
12. Glyceryl Oleate
13. Polysorbate 20
14. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Benzalkonium Chloride 0.23% w/w. Purpose: Antibacterial-Antifungal

Purpose

Antibacterial / Antifungal Wet Wipes

Use

Antibacterial Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Keep away from food and animal feeds. For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When Using this product do not inhale the vapour or grains of the product if occurs. Do not eat or drink or smoke while using the product. Follow all the instructions to avoid risks on human and environmental health. In case of inhaling: Give fresh air or oxygen. If you feel unwell, consult a doctor. In case of skin contact: This product is produced to contact with the skin. Seek a doctor if redness, swelling, itching, or burning occurs on skin. In case of contact with eyes:If you are wearing contact lenses,remove them immediately.Rinse your eyes with plenty of clean water. In case of swallowing: Rinse mouth. Do not vomiting. If unconscious, never give anything by mouth. If it is vomiting, do not lay it on its back and lay it on its side. Call your local Toxication Center and get medical help.

STOP USE

Seek a doctor if redness, swelling, itching, or burning occurs on skin.

KEEP OUT OF REACH OF CHILDREN

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

Directions

DIRECTIONS
Provides practical cleaning without the need of water and soap. It is used for hand cleaning. Open the label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rising required.

Other information

Store the product dry,cool,clean place and keep away from direct sunlight. Keep away from children and pets.

Inactive ingredients

Dehydroacetic Acid, Benzoic Acid, Lauryl Glucoside, Glycerin, Propylene Glycol, Etidronate Tetrasodium, Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester, Fatty-Acid Amide Hydrolase 1, Phenoxyethanol, Dicaprylyl Carbonate, Glyceryl Oleate, Polysorbate 20, Sterile distilled water

Package Label - Principal Display Panel

100 pcs NDC: 86815-003-01

15 pcs NDC: 86815-003-02

INGREDIENTS AND APPEARANCE

DEEP FRESH ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86815-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC)
FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERYL OLEATE (UNII: 4PC054V79P)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86815-003-01	100 g in 1 POUCH; Type 0: Not a Combination Product	03/30/2020
2	NDC: 86815-003-02	15 g in 1 POUCH; Type 0: Not a Combination Product	03/30/2020
3	NDC: 86815-003-04	80 in 1 CANISTER	03/30/2020
3	NDC: 86815-003-03	0.238464 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC: 86815-003-06	100 in 1 CANISTER	03/30/2020
4	NDC: 86815-003-05	0.29808 g in 1 PATCH; Type 0: Not a Combination Product
5	NDC: 86815-003-08	160 in 1 CANISTER	03/30/2020
5	NDC: 86815-003-07	0.4769 g in 1 PATCH; Type 0: Not a Combination Product
6	NDC: 86815-003-10	500 in 1 CANISTER	03/30/2020
6	NDC: 86815-003-09	1.4904 g in 1 PATCH; 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	03/30/2020

Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)

Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)

Establishment
Name	Address	ID/FEI	Business Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		365577706	manufacture(86815-003)