Label: WONVIA ANTIBACTERIAL 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 August 12, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Wonvia antibacterial wipes

  • Active Ingredient(s)

    Active material name and amount (%): (Chemical Name; CAS No.) Benzalkonium Chloride %0,23 (CAS NO: 68424-85-1)

  • Inactive ingredients

    Inactive material name: Aqua, Olus Oil, Lauryl Glucoside, Glycerin, Propylene Glycol, Polyglyceryl-2 Dipolyhydroxystearate, Phenoxyethanol, Parfum, Polysorbate 20, Glyceryl Oleate, Dicaprylyl Carbonate, Dehdroacetic Acid, Benzoic Acid, Tetrasodium EDTA, Benzyl Alcohol, Benzyl Salicylate, Citronellol, Coumarin, Linalool.

  • Purpose

    Antibacterial Wet Wipes.

  • DOSAGE & ADMINISTRATION

    It is illegal to use this product for uses or in a manner other than prescribed on this label

  • Use

    Antibacterial Wet Wipes. Cleans and softens the skin and provides a pleasant odor.

  • Warnings

    Non-edible.

  • Do not use

    Do not use on eyes.

  • STORAGE AND HANDLING

    Keep away from sunlight or direct heat and store at room temperature.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DISPOSAL AND WASTE HANDLING

    Dispose of contents/container in accordance with local regulations.

  • QUESTIONS

    1 888 8 WONVIA

    www.wonvia.com

  • Package Label - Principal Display Panel

    WONVIA antibacterial

    antibacterial wipes

    kills 99,9% of bacteria

    120 wipes

    effective hygiene wipes

    Use biocides safely and sustainably.

    Production date, expiry date and batch number are on the pack.

    Kaplan Distribution LLC

    828 N. OLDEN AVE. TRENTON, NJ 08638 USA

    Made in Turkey

    72120

    Produced under hygienic environment and conditions according to ISO 22716:2007 (GMP) and ISO 9001:2015 Quality Management System.

  • INGREDIENTS AND APPEARANCE
    WONVIA ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78876-707
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78876-707-72335 g in 1 PACKAGE; Type 0: Not a Combination Product06/16/2020
    2NDC:78876-707-12460 g in 1 PACKAGE; Type 0: Not a Combination Product06/16/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - Kaplan Distribution LLC (117548994)
    Registrant - HARDAL GLOBAL CONSULTING LLC (123584960)
    Establishment
    NameAddressID/FEIBusiness Operations
    KAPLAN DISTRIBUTION LLC117548994label(78876-707)
    Establishment
    NameAddressID/FEIBusiness Operations
    RKS GROUP YAPI KIMYASALLARI SANAYI VE TICARET LIMITED SIRKETI520136931manufacture(78876-707)