Label: ZETOX ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 23, 2022

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  • 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

    yellowgreen

  • INGREDIENTS AND APPEARANCE
    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)
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