Label: VIROCIDE ANTIBACTERIAL WIPES- benzalkonium chloride, isopropyl alcohol 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 October 7, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Benzalkonium Chloride 0.25%
    Isopropyl Alcohol 5%

  • PURPOSE

    Purpose
    Benzalkonium Chloride .......................... Antimicrobial Agent
    Isopropyl Alcohol ................................... Antimicrobial Agent

  • INDICATIONS & USAGE

    Uses decrease bacteria on skin.

  • WARNINGS

    Warnings
    For external use only.

  • WHEN USING

    When using this product, avoid contact with the eyes.
    In case of contact, rinse eyes thoroughly with water.

  • DO NOT USE

    Do not use if you are allergic to any of
    the ingredients.

  • WHEN USING

    When using this product do not get
    into eyes. If contact occurs, rinse
    thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation
    or rash develops and continues for
    more than 72 hours.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children   ■ apply to hands.
    2 years and over:     ■ allow to dry
                                        without wiping.
    children under 2 years: ask a doctor
    before using.

  • QUESTIONS

    Questions or Comments?
    (M-F 9AM-5PM)
    1(833)494-5459

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Aloe Vera (Aloe Barbadensis)
    Leaf, Anhydrous Citric Acid,
    Dimethicone, Edetate Sodium
    Tetrahydrate, Hydantoin,
    Polysorbate 20,Tocopheryl Acetate
    (Vitamin E), Glycerin, Fragrance,
    Methylchloroisothiazolinone,
    Methylisothiazolinone.

  • Package Label

    BOX OF 12-PACKETS

    77005-007 Box

    PACKET OF 100 WIPES

    77005-007 Packet

    res

  • INGREDIENTS AND APPEARANCE
    VIROCIDE ANTIBACTERIAL WIPES 
    benzalkonium chloride, isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77005-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.5 mg
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    HYDANTOIN (UNII: I6208298TA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77005-007-0212 in 1 BOX10/07/2020
    1NDC:77005-007-01100 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Virocide LLC (117469716)
    Registrant - Virocide LLC (117469716)
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