Label: AGACHY FAST CLEAN HAND SANITIZINGSPRAY- hand sanitizer 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 July 7, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

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

  • WHEN USING

    When using this product do not use in or near the eye. In case of contact with eyes, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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 cover all surfaces and rub hands together until dry.
    • Supervise children under 6 years of age 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, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

  • Package Label - Principal Display Panel

    100mL 77201-003-10

  • INGREDIENTS AND APPEARANCE
    AGACHY FAST CLEAN HAND SANITIZINGSPRAY 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77201-003
    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
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77201-003-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - ICOMAX Co., Ltd. (694834031)
    Establishment
    NameAddressID/FEIBusiness Operations
    ICOMAX Co., Ltd.694834031manufacture(77201-003)
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