Label: HAND SANITIZER MIST- alcohol 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 May 14, 2021

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  • ACTIVE INGREDIENT

    Alcohol 70% w/w

  • INACTIVE INGREDIENTS

    Water, Glycerin, Fragrance, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Sophora Angustifolia Root Extract

  • PURPOSE

    SANITIZER

  • WARNINGS

    • Flammable. Keep away from heat and flame.
    • For external use only.
    --------------------------------------------------------------------------------------------------------
    Do not use
    • on children less than 2 months old, or on open skin wounds.

    --------------------------------------------------------------------------------------------------------
    When using this product • avoid contact with 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, seek medical help or contact a Poison Control Center right away at (800) 222-1222.

  • Uses

    ■ to help reduce bacteria on skin.

  • Directions

    ■ Place enough sanitizer on hands to cover all surfaces.
    ■ Rub hands until dry.
    ■ Children should be supervised when using this product to avoid swallowing .

  • Other information

    ■ Store between 15-30°C (59-86°F)
    ■ Avoid freezing and excessive heat above 40°C (104°F)

  • Questions

    • FCO Genesis I, Inc

    • www.fcogen1.com

    • 1-888-970-7617

  • 71080-0023-1: Hand Sanitizer Mist (Heat)

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  • 71080-0023-2: Hand Sanitizer Mist (Knicks)

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  • 71080-0023-3: Hand Sanitizer Mist (Lakers)

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  • 71080-0023-4: Hand Sanitizer Mist (Nets)

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  • 71080-0023-5: Hand Sanitizer Mist (NBA)

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER MIST 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol11.9 g  in 17 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0023-117 mL in 1 CARTON; Type 0: Not a Combination Product05/10/2021
    2NDC:71080-0023-217 mL in 1 CARTON; Type 0: Not a Combination Product05/10/2021
    3NDC:71080-0023-317 mL in 1 CARTON; Type 0: Not a Combination Product05/10/2021
    4NDC:71080-0023-417 mL in 1 CARTON; Type 0: Not a Combination Product05/10/2021
    5NDC:71080-0023-517 mL in 1 CARTON; Type 0: Not a Combination Product05/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/10/2021
    Labeler - GTG WELLNESS CO., LTD. (689458057)
    Registrant - GTG WELLNESS CO., LTD. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Korea Co., Ltd.688729438manufacture(71080-0023)
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