Label: HYGENIX AF 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 June 17, 2021

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  • BOXED WARNING (What is this?)

    Drug Facts

    Active Ingredient

    Benzalkonium Chloride 0.1

    Antiseptic

    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 react 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, Acetamidoethoxyethanol, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    90 CT 74146-243-9390 CT 74146-243-93

  • PRINCIPAL DISPLAY PANEL

    74146-243-85 225 CT 74146-243-85

  • INGREDIENTS AND APPEARANCE
    HYGENIX AF WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-243
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-243-966 in 1 BOX06/17/2021
    1NDC:74146-243-93647.3 mL in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:74146-243-864 in 1 BOX06/17/2021
    2NDC:74146-243-85810.1 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 finalpart333A06/17/2021
    Labeler - GM Industrial, Inc. (025827197)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Industrial, Inc.025827197manufacture(74146-243) , label(74146-243) , pack(74146-243) , relabel(74146-243) , repack(74146-243)
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