ZETOX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

Zetox Antibacterial Wet Wipes by

Drug Labeling and Warnings

Zetox Antibacterial Wet Wipes by is a Otc medication manufactured, distributed, or labeled by SCK ZETA DIS TICARET. 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 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

• on open skin wounds

WHEN USING

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

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

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

Directions

• use wipes as much as needed, used by wiping the hands, between the fingers, all internal and external surfaces, and under the nails. Do not rinse after use.

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

INGREDIENTS AND APPEARANCE

ZETOX ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86818-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86818-004-02	120 in 1 PACKAGE	03/30/2020
1	NDC: 86818-004-01	0.74 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 86818-004-04	100 in 1 PACKAGE	03/30/2020
2	NDC: 86818-004-03	0.74 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 86818-004-06	80 in 1 PACKAGE	03/30/2020
3	NDC: 86818-004-05	0.74 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 - SCK ZETA DIS TICARET (356290986)

Registrant - SCK ZETA DIS TICARET (356290986)

Establishment
Name	Address	ID/FEI	Business Operations
SCK ZETA DIS TICARET		356290986	manufacture(86818-004)