Label: ALL STOP MEDICATED BODY WASH- benzalkonium chloride soap

  • NDC Code(s): 42355-265-05, 42355-265-14, 42355-265-19
  • Packager: Q-Based Solutions Inc
  • 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 July 9, 2019

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  • Drug Facts Box OTC-Active Ingredient Section

    Benzalkonium Chloride 2.5%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

    if swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box OTC-Dosage & Administration Section

    • wet hands and forearms
    • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
    • scrub thoroughly for 1 minute and rinse
  • Drug Facts Box OTC-Inactive Ingredient Section

    ater, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide,

    PEG-75 lanolin, citric acid, FD and C red no.4

  • All Stop Medicated Body Wash 6265 Drug Facts and Label

    product label

    All Stop Medicated Body Wash 6265 Drug Facts and Label

  • INGREDIENTS AND APPEARANCE
    ALL STOP MEDICATED BODY WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42355-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42355-265-05532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/2017
    2NDC:42355-265-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/2017
    3NDC:42355-265-1918900 mL in 1 CONTAINER; Type 0: Not a Combination Product12/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2017
    Labeler - Q-Based Solutions Inc (153509315)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(42355-265)
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