Label: ANTIBACTERIAL 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 2, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride%. Purpose: Antibacterial

  • Purpose

    Antibacterial

  • Use

    Antibacterial wet wipes to help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Directions

    • Wipe skin with the product and allow tol dry.
    • Discard wipes in trash receptacle after use. Do not flush.
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

  • Package Label - Principal Display Panel

    80 pcs label 80 pcs label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77490-013(NDC:52489-002)
    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
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) 0.0002 mL  in 1 mL
    CHLORPHENESIN (UNII: I670DAL4SZ) 0.0002 mL  in 1 mL
    PROPYLENE GLYCOL, (S)- (UNII: 942194N4TD) 0.0002 mL  in 1 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 0.0002 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.9941 mL  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0002 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77490-013-80360 mL in 1 PACKAGE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2020
    Labeler - On The Spot Products, LLC (117497833)
    Registrant - On The Spot Products, LLC (117497833)
    Establishment
    NameAddressID/FEIBusiness Operations
    On The Spot Products, LLC117497833relabel(77490-013)