Label: HAND SANITIZER- alcohol 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 23, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 70%

    Purpose

       Antiseptic

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or ​flame.  For external use only.

    When using this product

    Do not use in eyes.  In case of contact with eyes, rinse with water.

    Stop use and ask a doctor

    if irritation and redness develop and persist.

    Keep out of reach of children.

    If swallowed, get medical help promptly.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    Store under 105 oF

  • Inactive ingredients

    Aloe Barbadensis Leaf, Carbomer, Dimethicone, Triisopropanolamine, Water

  • Package Labeling: 1000L, 77811-001-01

    1000

  • Package Labeling: 3785mL, 77811-001-02

    3785

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77811-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77811-001-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/21/2020
    2NDC:77811-001-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2020
    Labeler - Aventi Medical, LLC (117518869)