Label: HAND SANITIZER FOAM- anti-bacterial advanced formula liquid

  • 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 22, 2022

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  • Purpose

    Antimicrobial

  • Uses

    *To help decrease bacterial on the skin. Recomended for repeated use as needed.

  • Warnings

    For external use only.

  • Stop Use

    *Stop use and consult with doctor if irritation and redness develops, or if condition persists for more than 24 hours.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

  • Directions

    * Pump a sufficient amount of foam into palm of hand.

    * Rub thoroughly over all surfaces of both hands.

    * Rub hands repeatedly until dry.

  • Other Information

    Do not store above 104 OF.

  • Inactive Ingredients

    Water, Glycerin, Hyaluronic Acid, Aloe Barbadensis Leaf Juice Powder, Quillaja Saponaria (Soapbark) Bark Extract, PEG-8 Dimethicone, Polyquaternium-7, PPG-26 Buteth-26, PEG-40 Hydrogenated Castor Oil, Sodium Decylglucosides Hydroxypropylsulfonate, Ethylhexylglycerin, Phenoxyethanol, Fragrance.

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • PDP

    LabelLabelMEDILAB

    365

    HAND SANITIZER FOAM

    ANTI-BACTERIAL

    ADVANCED FORMULA

    KILLS 99.99%

    OF GERMS

    REGISTERED CERTIFIED

    FDA GMP

    FORMULA FACILITY

    5 FL.OZ (150 ML)

    Hand Sanitizer Foam 1.7 fl.oz.

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER FOAM 
    anti-bacterial advanced formula liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72471-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72471-100-201 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2020
    2NDC:72471-100-211 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2020
    3NDC:72471-100-221 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/20/2020
    Labeler - VMP Cosmetics, LLC (022451337)
    Registrant - VMP Cosmetics, LLC (022451337)
    Establishment
    NameAddressID/FEIBusiness Operations
    VMP Cosmetics, LLC022451337manufacture(72471-100)
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