Label: DIPPIN DOTS ALCOHOL FREE 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 August 4, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0.13%.........Antibacterial

  • Purpose

    Antibacterial

  • Use

    To decrease bacteria on the skin and clean hands.

    Recommended for repeated uses.

  • Safety Instructions

    For extemal use only.

    Do not Eat Or Drink

    Flammable.Keep away from fire and flame.

  • When using this product

    In case of contact,rinse eyes thoroughly with water.

  • Do not use

    Do  not use in or near eyes.

  • KEEP OUT OF REACH OF CHILDREN

    If accidentally swallowed, seek medical help or contact Poison Control  center right away.

  • Inactive Ingredients

    Water (aqua), Polysorbate-20, PEG-40 Hydrogenated,Triethanolamine, Carbomer, Fragrance, Glycerin. Propylene Glycol, Calcium Sodium Borosilicate , Titanium Dioxide , Aloe Barbdensis Leaf Juice,Tocopheryl Acetate, Methylchloroisothiazolinone,Methylsothiazolinone ,Blue 1

    Yellow 5,Red 9.

  • Directions

    • apply palmful to hands.
    • rub hands together vigorously until dry.
    • supervise children in the use of this product.
  • PRINCIPAL DISPLAY PANEL

    dippin2

    2

  • INGREDIENTS AND APPEARANCE
    DIPPIN DOTS ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-026-792 in 1 PACKAGE08/03/2020
    179 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2020
    Labeler - Flex Beauty Labs (080858917)
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