Label: ANTISEPTIC SANITIZING WIPES (0.13% BENZALKONIUM CHLORIDE)- 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 November 12, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Do not use

    • in children less than 2 months of age
    • on open skin
  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Unfold towelette, wipe hands, discard after use.

    Rub thoroughly into hands for at least 30 seconds, allow to dry.

  • Directions

    Peel back flap on front to pull out a wipe.

    Unfold and wipe hands thoroughly.

    Reseal and let hands dry.

    No need to rinse.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    • Do not replace wipes used for medical procedures.
    • These wipes are meant for general cleansing.
  • Other information

    Store between 15-30℃ (59-86℉)

  • Inactive ingredients

    purified water USP

  • Package label. Principal display panel

    B-Pail-200

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SANITIZING WIPES (0.13% BENZALKONIUM CHLORIDE) 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79846-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79846-151-2150 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
    2NDC:79846-151-2360 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
    3NDC:79846-151-2572 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
    4NDC:79846-151-2780 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
    5NDC:79846-151-31100 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
    6NDC:79846-151-50100 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    7NDC:79846-151-52120 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    8NDC:79846-151-56160 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    9NDC:79846-151-58180 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    10NDC:79846-151-60200 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    11NDC:79846-151-90500 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
    12NDC:79846-151-0510 in 1 POUCH; Type 0: Not a Combination Product11/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/27/2020
    Labeler - Jintu Handicraft Factory (654443675)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jintu Handicraft Factory654443675manufacture(79846-151) , label(79846-151)
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