Label: DK12 LIQUID HAND OATMEAL- benzalkonium chloride 0.13% liquid

  • NDC Code(s): 62476-006-08
  • Packager: Industria La Popular, S.A.
  • 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 September 21, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    For washing to decrease bacteria on the skin

  • Warnings

    For External Use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.


    Stop use and ask a doctor

    irritation or redness develops - condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse thoroughly.

  • Other Information

    Store between 15-30C (59-86F)

  • Inactive Ingredients

    Aqua, Sodium Lauryl Ether Sulfate, Sodium Chloride, Glycol Distearate/Laureth-4/Cocamidopropyl Betaine, Cocamide MEA, Glycerin, Phenoxyethanol, Fragrance, Methylchloroisothiazolinone/Methylisothiazolinone, Citric Acid

  • DK12 Liquid Hand Soap Oatmeal

    labellabel

  • INGREDIENTS AND APPEARANCE
    DK12 LIQUID HAND OATMEAL 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURETH-4 (UNII: 6HQ855798J)  
    COCAMIDE (UNII: 3YXD33R71G)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-006-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2023
    Labeler - Industria La Popular, S.A. (846044576)
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