Label: INSTANT WIPE- 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 14, 2021

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  • BOXED WARNING (What is this?)

    Drug Facts

    Benzalkonium chloride 0.1%

    Antiseptic

    Uses

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately.

    Directions

    Wet hands thoroughly with product. Discard wipe in trash receptacle after use. Do not flush. Rub hands together briskly until dry.

    Other information

    Store in a cool dry place below 104 F

    Water, C9-11 Pareth-6, Cocamidopropyl PG-dimonium chloride phosphate, Dihydroxyethyl cocamine oxide, Acetamidoethanol, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    90 CT 74146-242-9790 CT 74146-242-97

  • PRINCIPAL DISPLAY PANEL

    225 CT 74146-242-87225 CT 74146-242-87

  • PRINCIPAL DISPLAY PANEL

    90 CT 74146-242-92

  • PRINCIPAL DISPLAY PANEL

    225 CT 74146-242-84 225 CT 74146-242-84

  • INGREDIENTS AND APPEARANCE
    INSTANT WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-242-976 in 1 BOX12/01/2020
    1NDC:74146-242-92647.3 mL in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:74146-242-874 in 1 BOX12/01/2020
    2NDC:74146-242-84810.1 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - GM Industrial, Inc. (025827197)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Industrial, Inc.025827197manufacture(74146-242) , pack(74146-242) , label(74146-242) , relabel(74146-242) , repack(74146-242)
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