Label: VITAL HEALTH CARE ADVANCED HAND SANITIZER- ethyl 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 January 6, 2021

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  • Active ingredient

    Ethyl Alcohol 70%

  • PURPOSE

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin.

  • 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

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

  • STOP USE

    if irritation or rash occurs. 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

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • ​Children under 6 years of age should be supervised when using this product.
  • OTHER SAFETY INFORMATION

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

    Glycerin, PEG-6 (and) AMP-Acrylate/vinyl-Isodecanoate Crosspolymer, Propylene-glycol, Purified Water

  • Vital Health Care Advanced Hand Sanitizer 7.8 oz

    VHC.JPG

  • INGREDIENTS AND APPEARANCE
    VITAL HEALTH CARE ADVANCED HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73787-127
    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
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73787-127-01228 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - FGD, LLC (111927555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodwin Co.806987483manufacture(73787-127)
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