Label: DIAL REFRESH AND RENEW ANTIBACTERIAL BAR SPRING WATER- benzalkonium chloride soap

  • NDC Code(s): 54340-300-01, 54340-300-03, 54340-300-04, 54340-300-08, view more
    54340-300-12
  • Packager: Henkel Corporation
  • 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 2, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.10%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Use

    For washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only

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

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

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

  • DOSAGE & ADMINISTRATION

    Directions • wet bar with water • lather vigorously and wash skin • rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients Soap (Sodium Palmate* • Sodium Palm Kernelate*• Sodium Cocoate* ) • Water • Glycerin • Stearic Acid* • Coconut Acid* • Palm Acid* • Palm Kernel Acid* • Fragrance • Titanium Dioxide • Sorbitol • Sodium Chloride • Tetrasodium Glutamate Diacetate • Alcohol

    *Contains one or more of these ingredients

  • QUESTIONS

    Questions? 1-800-258-DIAL (3425)

  • SPL UNCLASSIFIED SECTION

    Visit our website at www.dialsoap.com

    Henkel®, TM, ©2023 Distributed by

    Henkel Corporation, Rocky Hill, CT 06067

    Made in Columbia

  • PRINCIPAL DISPLAY PANEL

    Dial refresh & renew™

    DEODORANT BAR SOAP

    Antibacterial

    spring water® scent

    NET WT 4 OZ (113 g)

    label

  • INGREDIENTS AND APPEARANCE
    DIAL REFRESH AND RENEW ANTIBACTERIAL BAR  SPRING WATER
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54340-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    COCONUT ACID (UNII: 40U37V505D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITOL (UNII: 506T60A25R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    PALM ACID (UNII: B6G0Y5Z616)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    ALCOHOL (UNII: 3K9958V90M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54340-300-088 in 1 PACKAGE01/02/2023
    1113 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:54340-300-1212 in 1 PACKAGE01/02/2023
    2113 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:54340-300-033 in 1 PACKAGE01/02/2023
    3113 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:54340-300-01113 g in 1 PACKET; Type 0: Not a Combination Product01/02/2023
    5NDC:54340-300-044 in 1 PACKAGE01/02/2023
    5113 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/02/2023
    Labeler - Henkel Corporation (080887708)