Label: ACCUMED ANTIBACTERIAL HAND SANITIZING WIPES- 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 July 11, 2023

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  • DOSAGE & ADMINISTRATION

    Directions

    ■ Open resealable label, remove one wipe to use ■ Wipe hand thoroughly with product and allow to dry without wiping. ■ Close resealable label after use to retain moisture.

  • PURPOSE

    Antibacterial

    ■ For handwashing to decrease bacteria on the skin.

  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.11%

  • INACTIVE INGREDIENT

    Inactive ingredient 2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only.

    ■ Do not use on eyes. If eye contact occurs, rinse eyes thoroughly with water. ■ Do not flush.■ Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    A

  • INGREDIENTS AND APPEARANCE
    ACCUMED ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81204-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    3-HEXYLOXYPROPYLENE GLYCOL (UNII: 3485P35DA4)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81204-001-0130 in 1 POUCH07/15/2021
    12.9 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2021
    Labeler - ACCUMED BIOTECH LLC (079860728)
    Establishment
    NameAddressID/FEIBusiness Operations
    AHC Ltd413138557manufacture(81204-001)
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