Label: ACQUA DI GABRIEL- hand sanitizing mist spray

  • 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 September 3, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 80%- Antiseptic to help reduce bacteria that potentially can cause disease

  • INACTIVE INGREDIENT

    Allantoin

    Ultra Pure Water

    Silver

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Apply Defense Ag on hands rubbing together until dried. Repeat as often as necessary.

  • KEEP OUT OF REACH OF CHILDREN

    Adult supervision recommended for children under 6 years old.

  • WARNINGS

    Keep away form fire and flame.

    Flammable

    For external use on hands only.

    Keep out of eye, ears and mouth.

    If contact in eyes, flush thoroughly with water.

    Keep out of reach of children.

    If swallowed seek medical help immediately or call your poison control center.

    Store between 15-30 (58-86F)

    Avoid freezing and excessive heat above 40C (104F)

    Will damage wood finishes, plastics and some fabrics.

  • DO NOT USE

    Children less than 2 months of age or on open wounds.

  • DOSAGE & ADMINISTRATION

    Dosage: upto 10 times a day

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Administration:Topoical

  • PURPOSE

    Purpose: to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • PRINCIPAL DISPLAY PANEL

    4oz label 16oz back label16oz front label

  • INGREDIENTS AND APPEARANCE
    ACQUA DI GABRIEL 
    hand sanitizing mist spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79930-7103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z) 0.03 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 20 mL  in 100 mL
    SILVER (UNII: 3M4G523W1G) 0.5 mL  in 100 mL
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79930-7103-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/30/2020
    2NDC:79930-7103-4500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/30/2020
    Labeler - Nexderma Inc (079533940)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexderma Inc079533940manufacture(79930-7103) , pack(79930-7103) , label(79930-7103)
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