Label: JABON AVENA- benzalkonium chloride 0.1% soap

  • NDC Code(s): 62476-101-15, 62476-101-38
  • 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 June 21, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    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 and redness develops

  • Keep out of reach of children.

    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

    Sodium Palm Kernelate, Water, Glycerin, Fragrance (Perfume), Dimethicone, Butyrospermum Parkii (Shea Butter), Oatmeal Sativa Kernel Flour, Etidronic Acid, Titanium Dioxide, Prunus Amygdalus Dulcis (Sweet Almond) Oil

  • Questions

    1-801-0026227 or atencionalcliente@ilpsa.com

  • Jabón DK12 Avena

    labellabel

  • INGREDIENTS AND APPEARANCE
    JABON AVENA 
    benzalkonium chloride 0.1% soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 110 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PRUNUS DULCIS BARK (UNII: 32F32E1WJJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-101-38110 g in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2020
    2NDC:62476-101-15440 g in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/202003/31/2025
    Labeler - Industria La Popular, S.A. (846044576)
    Registrant - Industria La Popular, S.A. (846044576)
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