Label: PLANE IT SAFE HAND SANITIZER- hand sanitizer 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 4, 2020

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  • WARNINGS

    External Use Only

  • ACTIVE INGREDIENT

    Ethyl Alcohol 64%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. Adult supervision for children under 6 years old

  • STOP USE

    Stop use if redness or rash persists longer than 72 hours

  • PURPOSE

    To reduce bacteria on the hands

  • DOSAGE & ADMINISTRATION

    Apply throughly on hands and rub together until dry

  • INACTIVE INGREDIENT

    Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene, Glycol, Carbomer, Triethanolamine, Fragrance­­­­­­­­­­­­­­

  • INDICATIONS & USAGE

    Use as directed

  • WHEN USING

    Use to reduce bacteria on the hands

  • PRINCIPAL DISPLAY PANEL

    Plane It Safe 1oz Hand Sanitizer Back LabelPlane It Safe 1oz Hand Sanitizer front label

  • INGREDIENTS AND APPEARANCE
    PLANE IT SAFE HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72920-2012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72920-2012-129 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/08/2020
    Labeler - Plane It Safe LLC (106037472)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plane It Safe LLC106037472manufacture(72920-2012)
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