Label: DIAL REFRESH AND RENEW ANTIBACTERIAL MOUNTAIN FRESH- benzalkonium chloride soap

  • NDC Code(s): 54340-017-03, 54340-017-08
  • 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

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.10%

  • Purpose

    Antibacterial

  • Use

    • for washing to decrease bacteria on the skin.

  • Warnings

    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 if • irritation or redness develops.

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

  • Directions

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

  • Inactive ingredients

    Soap [sodium palmate* • sodium palm kernelate* • sodium cocoate*] • water • glycerin • stearic acid* • coconut acid* • palm acid* • palm kernel acid* • fragrance • titanium dioxide • sortibol • sodium chloride • tetrasodium glutamate diacetate • alcohol • yellow 5 • green 3

    *contains one or more of these ingredients

  • Questions?

    1-800-258-DIAL (3425)

  • SPL UNCLASSIFIED SECTION

    Dial ® refresh & renew™

    DEODORANT BAR SOAP

    ANTIBACTERIAL

    mountain fresh ®

  • PRINCIPAL DISPLAY PANEL

    ®, TM, © 2023 Distributed by

    Henkel Corporation, Rocky Hill, CT 06067

    Made in Colombia

    3-4 OZ SOAP BARS (113g), TOTAL NET WT 12 OZ (339g)

    label

  • INGREDIENTS AND APPEARANCE
    DIAL REFRESH AND RENEW ANTIBACTERIAL  MOUNTAIN FRESH
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54340-017
    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 PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT ACID (UNII: 40U37V505D)  
    PALM ACID (UNII: B6G0Y5Z616)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALCOHOL (UNII: 3K9958V90M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54340-017-033 in 1 PACKAGE11/22/2022
    1113 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:54340-017-088 in 1 PACKAGE11/22/2022
    2113 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 finalpart333E11/22/2022
    Labeler - Henkel Corporation (080887708)
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