Label: APRES FOAMING HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 42326-580-01
  • Packager: Petra Hygienic Systems International Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride – 0.13% w/v

    Purpose

    Antiseptic

  • Use(s)

    Effective in destroying (harmful) bacteria to provide antiseptic cleansing.

  • Warnings

    For external use only.

    Stop use and consult a doctor/healthcare provider if :

    Irritation develops

    Keep out of reach of children

    If swallowed, call a poison control center or get medical help.

  • Directions

    Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product. For occasional and personal domestic use.

  • Inactive Ingredients

    -Water, Cetyltrimethylammonium Chloride, Lauryltrimethylammonium Chloride, Dihydroxyethyl Cocoamine Oxide, Glycereth-17 Cocoate, Citric Acid, Fragrance

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    APRES FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42326-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42326-580-013700 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/07/2020
    Labeler - Petra Hygienic Systems International Limited (248228199)
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