Label: BLUEBERRY SCENTED HAND SANITIZER- benzalkonium chloride gel

  • 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 May 17, 2016

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Warnings

    • For external use only - hands.
    • Keep out of eyes. Avoid contact with broken skin.
    • Stop use and ask a doctor if irritation or redness develops.
    • Do not inhale or ingest. If swallowed, get medical help or contact a poison control center right away,

  • Directions

    • Rub a dime sized drop into hands.
    • For children under 6 use under adult supervision.
  • Inactive Ingredients

    water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance

  • Use

    To decrease bacteria on the skin that could cause disease.

  • PRINCIPAL DISPLAY PANEL

    sanitizer label

  • INGREDIENTS AND APPEARANCE
    BLUEBERRY SCENTED HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69795-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCETH-7 (UNII: 58Y261JLH5)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69795-007-0159 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/16/2016
    Labeler - Foshan Jinxiong Technology Co., Ltd (544328419)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Jinxiong Technology Co., Ltd544328419manufacture(69795-007)
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