Label: HAND SANITIZER 500ML- ethyle alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 August 27, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v..........................Antiseptic ACTIVE

  • Purpose

    Purpose.Antiseptic

    PURPOSE

  • Use[s]

    Use[s]-Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

    Use[s]

  • Warnings

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

    Warnings

  • Do not use

    Do not use-in children less than 2 months of age, on open skin wounds

    Do not use

  • When using this product

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

    When using this product

  • Stop use and ask a doctor

    Stop use and ask a doctor-if irritation or rash occurs. These may be signs of a serious condition.

    Stop use and ask a doctor

  • 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.

    Keep out of reach of children

  • Directions

    Directions-Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

    Directions

  • Other Information

    Other Information. Storage and Handling-Store between 15-30C (59-86F), ▪ Avoid freezing and excessive heat above 40C (104F)

    Other Information

  • Inactive ingredients

    Inactive ingredients-Water, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

    Inactive ingredients

  • Questions or Comments

    Questions or Comments 1-800-819-4159

    Questions or Comments

  • Principal Display Panel

    EPU INSTANT HAND SANITIZER NON-STERILE SOLUTION Help Reduce Bacteria On The Skin.
    For all day use, No Sticky, Deep Moisturizing, 500 mL (16.9 fl. oz.)

    PDP

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 500ML 
    ethyle alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-202
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73862-202-1124 in 1 CASE04/01/2020
    1NDC:73862-202-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - E.CIS Cosmetic Co.,Ltd (689846270)
    Registrant - E.CIS Cosmetic Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS Cosmetic Co.,Ltd689846270manufacture(73862-202)
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