Label: HAND SANITIZER- alcohol, water 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 June 8, 2020

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  • Active Ingredient

    Active Ingredient70 % Alcohol vv Purpose: Antiseptic

  • DOSAGE & ADMINISTRATION

    Dosage

  • INACTIVE INGREDIENT

    Inactive

  • INDICATIONS & USAGE

    Indication and Usage

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Children

  • PURPOSE

    Propose Section

  • WARNINGS

    Warning Section

  • PRINCIPAL DISPLAY PANEL

    package Picture2ml NDC 78837-202-20

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol, water gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78837-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1-(3,4-DIMETHOXYPHENYL)PROPANE-1,2-DIOL (UNII: N6222F124L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78837-202-201 mL in 1 PACKET; Type 0: Not a Combination Product06/12/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - Phoenix Wipes Inc (117544823)