Label: ADVANCED CLEAN HAND SANITIZER MIST- hand sanitizer liquid

  • 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 27, 2020

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  • Active Ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

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

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

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of 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 your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.
    • Supervise children when using this product to avoid swallowing.
  • Other Information

    • Avoid freezing and excessive heat above 104°F(40°C).
    • May discolor certain fabrics or surface.
  • Inactive Ingredients

    Water, Butylene Glycol, Glycerin, L-Menthol, Aloe Vera Leaf, Green Tea Leaf

  • Qusetions?

    1.310.635.7007

  • Package Label - Principal Display Panel

    500mL NDC: 75484-003-50

  • INGREDIENTS AND APPEARANCE
    ADVANCED CLEAN HAND SANITIZER MIST 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75484-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75484-003-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - SYNERGYPLANETS INC. (695720324)
    Registrant - SYNERGYPLANETS INC. (695720324)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmer's grain korea694439983manufacture(75484-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ICOMAX Co., Ltd.694834031manufacture(75484-003)
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