Label: DIAL COMPLETE SPRING WATER FHW solution

  • 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 April 17, 2020

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  • DRUG FACTS

  • Benzalkonium Chloride 0.13%


    Active ingredient Purpose

    Benzalkonium Chloride 0.13%......................................... Antibacterial

  • Purpose

    Antibacterial

  • Use

    For handwashing to decrease bacteria on the skin.

  • Warning

    For external use only.


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

  • Stop use and ask a doctor.

    Stop use and ask a doctor if irritation or redness develops.

  • 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.

  • Directions


    Directions
    • Pump into DRY hands
    • Lather vigorously for at least 15 seconds
    • Rinse and dry thoroughly

  • Inactive Ingredients


    Inactive Ingredients: Aqua (Water, Eau) • Glycerin •
    Lauramine Oxide • Cetrimonium Chloride • Cocamidopropyl Betaine •
    Citric Acid • Sodium Benzoate • Hydroxypropyl Methylcellulose •
    Parfum (Fragrance) • Zinc Sulfate • Sodium Chloride • Dimethyl
    Lauramine • Tetrasodium EDTA • Alcohol • Dimethyl Myristamine •
    CI 42090 (Blue 1) • CI 17200 (Red 33)

  • SPL UNCLASSIFIED SECTION

    *Encountered in household settings
    #Antibacterial Hand Soap
    REFILL ONLY WITH DIAL COMPLETE® FOAMING HAND WASH

  • Questions


    1-800-258-DIAL (3425)

  • SPL UNCLASSIFIED SECTION


    ®,TM,©2019 Distributed by
    Henkel Corporation,
    Rocky Hill, CT 06067
    www.dialsoap.com

  • DOSAGE & ADMINISTRATION

    Topical Liquid

  • For handwashing to decrease bacteria on the skin.

    KILLS MORE BACTERIA

    Than Ordinary Liquid Hand Soap

  • Principal Display Panel

    Drug FactFront

  • INGREDIENTS AND APPEARANCE
    DIAL COMPLETE SPRING WATER FHW 
    dial complete spring water fhw solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50663-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 94.27 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50663-242-02221 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Zotos International Inc (966706145)
    Registrant - Zotos International Inc (966706145)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zotos International Inc966706145manufacture(50663-242)
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