Label: SAN-EZ HAND SANITIZER- ethyl alcohol 70% gel

  • NDC Code(s): 55346-3302-1
  • Packager: Dental Technologies, Inc.
  • 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 April 8, 2020

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  • Active ingredient

    70% v/v Ethyl Alcohol

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help reduce microbes that potentially can cause disease.

    • For use when soap and water are not available.
  • Warnings

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

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash occures. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hand to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30ºC (59-86ºF)
    • Avoid freezing and excessive heat above 40ºC (104ºF)
  • Inactive ingredients

    Water, Isopropyl Alcohol, Carbomer, Fragrance, Aminomethyl Propanol

  • Questions or comments?

    Call 1-800-835-0885

  • Principal Display Panel

    SAN-EZ™

    Gel

    Hand Sanitizer

    Essened with Aloe & Shea

    8 fl. oz. (236mL)

    REF 033.0202.002

    PM5629 REV.000.jpg

  • INGREDIENTS AND APPEARANCE
    SAN-EZ HAND SANITIZER 
    ethyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-3302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    DIMETHYL BENZYL CARBINOL (UNII: N95NCI59MI)  
    TRICYCLODECENYL PROPIONATE (UNII: 7MGZ636C87)  
    4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ACETYL CEDRENE (UNII: X6I62755AK)  
    ACETYL HEXAMETHYL TETRALIN (UNII: 360Q8Z01IP)  
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    CITRAL (UNII: T7EU0O9VPP)  
    2-METHYL-4-PHENYL-2-BUTANOL (UNII: 9Y5UX90TZ4)  
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55346-3302-1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/08/2020
    Labeler - Dental Technologies, Inc. (148312838)
    Registrant - Dental Technologies, Inc. (148312838)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(55346-3302) , pack(55346-3302) , label(55346-3302)
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