Label: BZK PADS- benzalkonium chloride swab

  • NDC Code(s): 67777-244-01, 67777-244-02
  • Packager: Dynarex Corporation
  • 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 29, 2022

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  • Active Ingredient

    Benzalkonium Chloride 0.13% v/v

  • Purpose

    First Aid Antiseptic

  • Uses

    • For perineal and maternity care throughout postpartum and whenever refreshing is needed.

  • Warnings

    For external use only

    Do not use

    • In the eye

    Stop use and ask a doctor if

    • Irritation and redness develop

    • If condition persists for gets worse

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Unfold towel

    • Cleanse the desired area

    • Dispose of towlette after single use.

  • Other Information

    • Store at room temperature 15º-30ºC (59º-86ºF)

    • Avoid excessive heat.

    • Tamper evident. Do not use if packet is torn or cut.

  • Inactive ingredients

    Chlorothymol, Isopropyl Acohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone

  • Label

    1302 BX MASTER1302 Label

  • Label

    1302 MNFL0101302 Obstetrical Towelette

  • INGREDIENTS AND APPEARANCE
    BZK PADS 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-244-0110 in 1 CASE04/05/2011
    1NDC:67777-244-02100 in 1 BOX
    10.55 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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