Label: G AND Y ANTIBACTERIAL 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 February 1, 2022

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  • Active Ingredients

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

  • Do not use

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

  • When using this product

    if eye contact occurs, rinse eyes thoroughly with water

  • Keep out of reach of children.

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

  • STOP USE

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

  • Cloth

  • Directions

    • Storage: Store at room temperature.
    • Dispensing: Peel back label slowly. Pull out wipe and reseal label. Close label to retain moisture.
    • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
    • Disposal: Dispose of used wipes in trash receptable after use. Do not flush.

  • Inactive Ingredients

    Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol,

  • 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 Antibacterial Wet Wipes 90

  • INGREDIENTS AND APPEARANCE
    G AND Y ANTIBACTERIAL WET WIPES 
    g and y antibacterial wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80903-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 3.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80903-013-9090 in 1 PACKAGE07/03/2020
    13.5 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
    ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI565415460manufacture(80903-013)
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