Label: DICTUM ANTIBACTERIAL TOWEL- benzalkonium chloride swab

  • 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 23, 2020

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

  • Purpose

    Antiseptic: Hand Sanitizer Swab
    Hand Sanitizer Swab to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • INDICATIONS & USAGE

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes
    thoroughly with warter.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious contiditon.
    Keep our of reac of children. If swallowed, get medical help or contact a Poison Control Center right
    away.
    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. If swallowed, get medical help or contact a Poison Control Center right
    away.
    Place enough product on hands to cover all surfaces. Rub hand together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.
    Store between 15-43C (59-110F)
    Avoid freezing and excessive heat above 43C (110F)

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

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

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

  • Active Ingredients

    BENZALKONIUM CHLORIDE 0.2 g

    DIDECYLDIMONIUM CHLORIDE 0.05 g

  • Inactive Ingredients

    WATER

    FRAGRANCE CLEAN 0.25 g

  • Warnings

    For external use only. Flammable. Keep away from the heat of the flame.

  • Dosage

    BENZALKONIUM CHLORIDE F5UM2KM3W7 0.2 g ACTIB

    DIDECYLDIMONIUM CHLORIDE JXN40O9Y9B 0.05 g ACTIB

    WATER 059QF0KO0R IACT

    FRAGRANCE CLEAN ORC0600327 329LCV5BTF 0.25 gIACT

  • PRINCIPAL DISPLAY PANEL

    wipe_label

  • INGREDIENTS AND APPEARANCE
    DICTUM ANTIBACTERIAL TOWEL 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79780-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.25 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79780-105-0125 g in 1 PACKET; Type 0: Not a Combination Product03/30/2020
    2NDC:79780-105-0250 g in 1 PACKET; Type 0: Not a Combination Product03/30/2020
    3NDC:79780-105-03100 g in 1 PACKET; Type 0: Not a Combination Product03/30/2020
    4NDC:79780-105-04150 g in 1 PACKET; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS (502991071)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEB Kozmetik Urunleri Imalat Sanayi Ticaret AS502991071manufacture(79780-105)