Label: HAND SANITIZER- isopropyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 29, 2020

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  • ACTIVE INGREDIENT

    Isopropyl alcohol 70% v/v...................... Antiseptic

  • Active ingredient[s] Purpose

    Isopropyl alcohol 70% v/v...................... Antiseptic

  • Use[s]

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

  • Warnings

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

  • Do not use

    in 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 occurs. These may be signs of a serious condition.

  • 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 on hands 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 below 110°F (43°C)

    May discolor certain fabrics or surfaces

  • Inactive ingredients

    water, glycerin, carbomer, triethanolamine, fragrance, color additive

  • PRINCIPAL DISPLAY PANEL

    66 ml NDC: 80311-252-21

    252 Front

    252 Back

    66 ml NDC: 80311-000-21

    000 Front

    000 Back

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80311-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.705 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80311-252-2166 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/07/2020
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80311-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.705 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    METHYL IONONES (UNII: EL78BGX1LO)  
    WATER (UNII: 059QF0KO0R)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Product Characteristics
    Colorwhite (clear gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80311-000-2166 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/07/2020
    Labeler - Mesa Lavender Farms (035642809)
    Registrant - Mesa Lavender Farms (035642809)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mesa Lavender Farms035642809manufacture(80311-252, 80311-000)
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