Label: ULTRA DEFENSE SANI SMART 2PK HAND SANITIZER- alcohol kit

  • 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 24, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 69% v/v

  • Purpose

    Antiseptic

  • Use

    for hand-washing to decrease bacteria on the skin, only when water is not available

  • Warnings

    For external use only

    Flammable, keep away from fire and flames

    When using this product

    • do not get into eyes.
    • if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    Raspberry

    Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Blue 1, Red 33.

    Strawberry

    Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Red 33.

  • Company Information

    MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC. NEW YORK, NY 10016

    ORIGIN: CHINA

  • Product Packaging

    strawberryraspberry

  • INGREDIENTS AND APPEARANCE
    ULTRA DEFENSE SANI SMART 2PK HAND SANITIZER 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-987
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74177-987-011 in 1 KIT; Type 0: Not a Combination Product11/24/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 50 mL
    Part 21 BOTTLE, PLASTIC 50 mL
    Part 1 of 2
    ULTRA DEFENSE SANI SMART STRAWBERRY HAND SANITIZER 
    alcohol gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/24/2020
    Part 2 of 2
    ULTRA DEFENSE SANI SMART RASPBERRY HAND SANITIZER 
    alcohol gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/24/2020
    Labeler - K7 Design Group Inc. (080357784)
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