Label: INSTANT FOAMING HAND SANITIZER- alcohol soap

  • NDC Code(s): 56131-701-29
  • Packager: RD Food Service DBA Restaurant Depot
  • 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 April 11, 2019

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Uses

    • Use hand sanitizer to reduce microorganisms on the skin.
    • Use this product when soap and water are not available.
  • Warnings

    • For external use only. Do not ingest.
    • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition.
    • Avoid contact with eyes. In case of eye contact, flush with large quantities of water, seek medical attention if irritation persists.
    • If skin irritation develops, discontinue use. If irritation persists for more than 72 hours, seek medical attention.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • ​Read the entire label before using this product.
    • ​Dispense 2 pumps of product onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
  • Inactive Ingredients

    Water, Propylene Glycol, Acrylic Polymer, Alkyl Phosphate Salts, Fragrance, DC Green #5.

  • Purpose

    Antiseptic

  • Alcohol Foaming Hand Sanitizer

    KEEP OUT OF REACH OF CHILDREN

  • Alcohol Foaming Hand Sanitizer

    RD_755

    RD 755

  • INGREDIENTS AND APPEARANCE
    INSTANT FOAMING HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56131-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56131-701-291000 mL in 1 BAG; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2016
    Labeler - RD Food Service DBA Restaurant Depot (878186774)
    Registrant - Betco Corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(56131-701) , label(56131-701)
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