Label: G AND Y DISINFECTING WET WIPES 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 December 25, 2020

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

  • Active Ingredient(s)

    Benzalkonium Chloride 0.2% w/w

  • Purpose

    Antimicrobial

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • Do not use

    Do not use

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

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

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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Cloth

  • 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
  • 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,

  • Other information

    Production Date, Expiry Date and Lot Number on side.

  • Package Label

    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

    G&Y Disinfecting Wet Wipes

  • INGREDIENTS AND APPEARANCE
    G AND Y DISINFECTING WET WIPES 
    g and y disinfecting wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80903-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 3.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80903-012-9090 in 1 PACKAGE07/03/2020
    13.8 mL in 1 PACKAGE; 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 - G&Y PRODUCTS INC. (081236664)
    Registrant - G AND Y PRODUCTS INC. (081236664)
    Establishment
    NameAddressID/FEIBusiness Operations
    G&Y PRODUCTS INC.081236664manufacture(80903-012) , label(80903-012)