Label: SHOT DOWN ANTIBACTERIAL WET 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 January 15, 2021

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  • Drugs Facts

  • Active ingredient

    Benzalkonium Chloride 0.20%

  • Purpose

    Antiseptic

  • Uses

    • For hand washing to decrease bacteria on the skin. Recommended for repeat use.

  • Warnings

    • For external use only.
    • Keep out reach of eyes. If contact occurs, rinse thoroughly with water.
    • Do not use if you are allergic to any of the ingredients.
    • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

    • Keep out of reach of children unless under adult supervision.
    • If swallowed, get medical help, or contact a Poison Control Center immediately.

  • Directions

    • Open resealable label and pull one sheet from pack. Thoroughly clean hands or affected area and discard in receptacle, and do not flush. Allow to dry without wiping. Be sure to reseal label complete to retain moisture.

  • Other information

    • Store at room temperature.

  • Inactive ingredients

    Citric Acid, Essential Oil Of Laurel, Lavender, Eucalyptus, Olive Oil, Parfum, Water

  • Questions? +1 716 507 4313

    • You may also report serious side effect to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Distributed By
    Home Kare Products Inc.

    3755 Haarlem Rd.
    Buffalo NY 14215
    USA

    PRODUCT OF TURKEY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SHOT DOWN  ANTIBACTERIAL WET WIPES
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81402-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BAY LEAF OIL (UNII: 5UMH0U3W0V)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81402-101-0140 in 1 PACKET01/01/2021
    13.6 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2021
    Labeler - Private Label Aerosol Dolum Sanayi Ticaret Anonim Sirketi (519987483)
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