Label: G AND Y DISINFECTING 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 July 3, 2020

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.2% w/w

  • Purpose

    Antimicrobial

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warning

    For external use only

    Do not use

    ▪ in the eyes.
    ▪ if you are allergic to any of the ingredients.

    When using this product  if eye contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

  • Directions

    • Storage. Store at room temperature.

    • Dispensing. Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture.

    • Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.

    • Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

  • Other information

    Production Date, Expiry Date and Lot Number on side

  • Inactive ingredients

    Benzoic Acid, C12-14-Alkyldimethyl(Ethylbenzyl)Ammonium Chloride, C12-15 Pareth-12, Dehydroacetic Acid, Didecyl Dimethyl Ammonium Chloride, Ethyl Alcohol, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate,

  • SPL UNCLASSIFIED SECTION

    Kills 99.9% of Germs that may cause illness.

    6.3 IN x 7.1 IN
    (16 cm x 18 cm)

    Questions? +1 (862) 257-3339

    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM 

    Distributed by: G&Y Products, Inc.

    25 Shady St, Paterson, NJ 07524

    info@gyproduct.com

    Country of origin : Turkey

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    G AND Y DISINFECTING WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77613-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77613-012-9090 in 1 PACKAGE07/03/2020
    13.8 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2020
    Labeler - ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (565415460)
    Establishment
    NameAddressID/FEIBusiness Operations
    ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI565415460manufacture(77613-012)
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