Label: WET NAP ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 10819-7012-1, 10819-7012-2, 10819-7012-3, 10819-7012-4, view more
    10819-7012-5
  • Packager: Professional Disposables International Inc.
  • 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 24, 2016

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

  • Active Ingredient

    Benzalkonium chloride 0.13% w/w

  • Purpose

    Antiseptic handwash

  • Use

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use in the eyes.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

  • Keep out of reach of children

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

  • Directions

    Directions for container:

    • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point, feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
    • Use as part of your hand cleaning routine.
    • Run product onto hands and allow to dry.
    • Discard after single use.

    Directions for packets or flowrap: see on container the directions to retreive the wipe.

  • Inactive ingredients

    Purified Water, SD Alcohol 40, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance

  • Principal Display panel

    Wet Naps

    Antibacterial Hand Wipes

    Moisturizes with Aloe

    Kills 99.99% of Germs

    Citrus Scent

    Front Canister: front

    Back Canister: back

    Packet: packet

    Box: box

    flowrap: flowrap

    Bonus 30ct box: box citrus30ct

    Bonux 54ct canister: front citrus 54ct

  • INGREDIENTS AND APPEARANCE
    WET NAP  ANTIBACTERIAL HAND WIPES
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-7012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-7012-1193.1 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/2014
    2NDC:10819-7012-224 in 1 BOX01/01/2014
    24.4 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:10819-7012-320 in 1 CELLO PACK01/01/2016
    32.6 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:10819-7012-430 in 1 BOX08/01/2016
    44.4 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:10819-7012-5266 mL in 1 CANISTER; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2014
    Labeler - Professional Disposables International Inc. (800777117)
    Registrant - Professional Disposables International Inc. (800777117)