Label: ADVANCED 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 November 19, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on the skin that can cause disease. recommended for repeat use

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    Do not use in or near the eyes. in case of contact, rinse thorougly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product in your palm to thorougly cover your hands. Rub hands together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110FC (43C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Carprylyl Glycol, Aloe Vera, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Yellow 5 and Blue 1.

  • Package Label - Principal Display Panel

    3.78L Label3.78 L NDC: 78257-919-01

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78257-919
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78257-919-013780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/16/2020
    Labeler - DEALMED MEDICAL SUPPLIES LLC (078864775)
    Establishment
    NameAddressID/FEIBusiness Operations
    PELICAN GROUP LLC, THE078435913manufacture(78257-919)
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