DEEP FRESH ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
AKSAN KOZMETIK 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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DEEP FRESH ANTIBACTERIAL WET WIPES

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

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.

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

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

100 pcs

15 pcs NDC: 86815-003-02

15 pcs

80pcs

500pcs

100pcs160pcs

DEEP FRESH ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86815-003-01100 g in 1 POUCH; Type 0: Not a Combination Product03/30/2020
2NDC:86815-003-0215 g in 1 POUCH; Type 0: Not a Combination Product03/30/2020
3NDC:86815-003-0480 in 1 CANISTER03/30/2020
3NDC:86815-003-030.238464 g in 1 PATCH; Type 0: Not a Combination Product
4NDC:86815-003-06100 in 1 CANISTER03/30/2020
4NDC:86815-003-050.29808 g in 1 PATCH; Type 0: Not a Combination Product
5NDC:86815-003-08160 in 1 CANISTER03/30/2020
5NDC:86815-003-070.4769 g in 1 PATCH; Type 0: Not a Combination Product
6NDC:86815-003-10500 in 1 CANISTER03/30/2020
6NDC:86815-003-091.4904 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
Establishment
NameAddressID/FEIBusiness Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI365577706manufacture(86815-003)

Revised: 4/2022
Document Id: dc20b4de-504c-8727-e053-2995a90a5209
Set id: a798d782-a3d0-37f4-e053-2a95a90ab741
Version: 6
Effective Time: 20220408
 
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI