Label: HAND SANITZER GEL - ALOE SCENT- hand sanitzer gel 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 14, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • When using this product:

    Keep away from eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use

    Stop use and ask a doctor if irritation occurs.

  • Keep away from children.

    Keep away from children. Contact poison control if swallowed.

  • Directions:

    Coat hands completely. Rub hands together until dry. Supervise children under 6 years old.

  • Other Information:

    Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

  • Inactive Ingredients:

    Alpha Tocopherol Acetate, Isopropyl Myristate, Glycerin, Water, Rapidgel ez1.

  • Package Label

    1.5 mL Sachet NDC: 76937-001-01

    1.5mL Sachet Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITZER GEL - ALOE SCENT 
    hand sanitzer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76937-001(NDC:74221-004)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76937-001-031008 in 1 BOX06/01/2020
    1NDC:76937-001-02120 in 1 CARTON
    1NDC:76937-001-010.0015 L in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Total Packaging Services (078330066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Total Packaging Services078330066repack(76937-001)