Label: FUSONI HAND SANITIZER WITH MOISTURIZER PLUS BLUE- alcohol gel
FUSONI HAND SANITIZER WITH MOISTURIZER PLUS- 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 July 7, 2020

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  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to decrease bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    Flammable, keep away from source of heat, fire or flame.
    For external use only. Do not inhale or ingest.

  • When using this product

    do not use in or near the eyes; if contact occurs, rinse eyes
    thoroughly with water.

    avoid contact with broken skin.

  • Stop use and ask a doctor if

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

  • Keep out of reach of children

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

  • Directions

    place enough product in your palm to thoroughly cover your hands and rub them together until dry.
    children under 6 years of age should be supervised when using this product.

  • Other information

    do not store above 109°F (43°C).
    may discolor certain surfaces or fabrics.

  • Inactive ingredients

    Product 011 "DRUG FACTS Fusoni Hand Sanitizer Plus.jpg":

    Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Ammonium Hydroxide.

    Product 012 "DRUG FACTS Fusoni Hand Sanitizer Plus Blue.jpg":

    Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Blue 1, Ammonium Hydroxide.

  • PRINCIPAL DISPLAY PANEL

    3.8 L NDC: 79380-011-12 DRUG FACTS Fusoni Hand Sanitizer PlusFront label Fusoni Hand Sanitizer Plus

  • PRINCIPAL DISPLAY PANEL

    DRUG FACTS Fusoni Hand Sanitizer Plus BlueFront label Fusoni Hand Sanitizer Plus Blue3.8 L NDC: 79380-012-12

  • INGREDIENTS AND APPEARANCE
    FUSONI HAND SANITIZER WITH MOISTURIZER PLUS BLUE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79380-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIA (UNII: 5138Q19F1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79380-012-110.946 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:79380-012-123.785 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    3NDC:79380-012-1318.93 L in 1 PAIL; Type 0: Not a Combination Product07/07/2020
    4NDC:79380-012-14208.18 L in 1 DRUM; Type 0: Not a Combination Product07/07/2020
    5NDC:79380-012-151003.03 L in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    FUSONI HAND SANITIZER WITH MOISTURIZER PLUS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79380-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIA (UNII: 5138Q19F1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79380-011-110.946 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:79380-011-123.785 L in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    3NDC:79380-011-1318.93 L in 1 PAIL; Type 0: Not a Combination Product07/07/2020
    4NDC:79380-011-14208.18 L in 1 DRUM; Type 0: Not a Combination Product07/07/2020
    5NDC:79380-011-151003.03 L in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - Fusoni S.A. de C.V. (811412535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fusoni S.A. de C.V.811412535manufacture(79380-011, 79380-012) , pack(79380-011, 79380-012) , label(79380-011, 79380-012)
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