ZETOX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
SCK ZETA DIS TICARET

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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Zetox Antibacterial Wet Wipes

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain 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 0.2 % ( w/w )
  2. Glycerin
  3. Phenoxyethanol
  4. Water
  5. Benzoic Acid
  6. Etidronate Tetrasodium
  7. Peg-7 Glyceryl Cocoate
  8. Polysorbate 20
  9. Melaleuca Alternifolia Leaf
  10. Ethylhexylglycerin
  11. Cocamidopropyl Betaine
  12. Anhydrous Citric Acid
  13. Dehydroacetic Acid 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 0.2% w/w. Purpose: Antibacterial

Purpose

Antiseptic, Antibacterial, Hand Sanitizer

Use

It is an ideal product that provides fast cleaning for your skin with its ready-to-use structure. You can easily use it at home, outside, in car and during travel. User group personal and general use.

Warnings

For external use only.

Before using, certainly read the label and the instructions.

Do not use

When using this product Keep out of reach of children, food and animal feeds. Do not eat, dirnk and smoking. Follow use instructions to prevent risks on human and environmental health.If contact the skin: This product is produced to contact the skin. Wash the excess with water. In case of redness, swelling, itching or burning occurs, get medical help.In case of eye contact: wash the eyes with the clean water at least 15 minutes with the eyes cover open. If swallowed shake the mouth with water. Do not induce vomiting. Immediately apply to the doctor and show him the label of the product.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Store below 30C (86F

Inactive ingredients

Glycerin, Phenoxyethanol, Water, Benzoic Acid, Tetrasodium EDTA, Peg-7 Glyceryl Cocoate, Polysorbate 20, Melaleuca Alternifolia Leaf Extract, Parfum, Ethylhexylglycerin, Cocamidopropyl Betaine, Citric Acid,Dehydroacetic Acid

Package Label - Principal Display Panel

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ZETOX ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86818-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86818-004-02120 in 1 PACKAGE03/30/2020
1NDC:86818-004-010.74 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:86818-004-04100 in 1 PACKAGE03/30/2020
2NDC:86818-004-030.74 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:86818-004-0680 in 1 PACKAGE03/30/2020
3NDC:86818-004-050.74 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 - SCK ZETA DIS TICARET (356290986)
Registrant - SCK ZETA DIS TICARET (356290986)
Establishment
NameAddressID/FEIBusiness Operations
SCK ZETA DIS TICARET356290986manufacture(86818-004)

Revised: 1/2022
Document Id: d647ec84-f78e-4beb-e053-2a95a90a06b6
Set id: b0393330-21af-fbb2-e053-2a95a90a64b8
Version: 3
Effective Time: 20220123
 
SCK ZETA DIS TICARET