Label: ULTRA DEFENSE SANI SMART MOISTURIZING AND 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 October 29, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 69% v/v

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    • irritation and redness develop and persist for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • Spray directly on hands and rub in thoroughly
    • For children under 6, use adult supervision
    • Not recommended for infants
  • Other information

    • Store between 15-30 C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Fragrance, Denatonium Benzoate.

  • Company Information

    MANUFACTURED FOR & DISTRIBUTED BY K7 DESIGN GROUP LLC. 2433 KNAPP STREET, BROOKLYN, NY 11235

    ORIGIN: CHINA

  • Product Packaging

    kit1

  • INGREDIENTS AND APPEARANCE
    ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZER 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74177-955
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74177-955-011 in 1 KIT; Type 0: Not a Combination Product10/14/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, SPRAY 100 mL
    Part 21 BOTTLE, PLASTIC 73 mL
    Part 1 of 2
    ULTRA DEFENSE SANI SMART HAND SANITIZER 
    alcohol spray
    Product Information
    Item Code (Source)NDC:74177-954
    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
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74177-954-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/14/2020
    Part 2 of 2
    ULTRA DEFENSE SANI SMART MOISTURIZING HAND 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPOLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    173 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/14/2020
    Labeler - K7 Design Group Inc. (080357784)
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