Label: APOL HAND SANITIZER- 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 5, 2020

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  • Active ingredient

    Ethanol 65%

  • Purpose

    Antiseptic

  • Use

    Hand clean sanitizer to help reduce bacteria on skin

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • When using this product

    do not use in or near the eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    irritation or rash appears and last.

  • Keep out of reach of children.

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

  • Directions

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

    Children under 6 years of age should be supervised when using this product.

  • Other information

    Store between 15-30C(59-86F)

    Avoid freezing and excessive heat above 40C(104F)

  • Inactive ingredients

    Water, Glycerin, Propylene glycol, Carbomer, Aloe Vera gel Triethanolamine, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Chamaecyparis Lawsoniana Wood Oil

  • Package Label

    500ml NDC: 80082-201-01 Label

  • INGREDIENTS AND APPEARANCE
    APOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80082-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMAECYPARIS LAWSONIANA WOOD OIL (UNII: 0H3D02DVNU)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80082-201-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2020
    Labeler - ECOSEM CO., LTD (695632865)
    Registrant - ECOSEM CO., LTD (695632865)
    Establishment
    NameAddressID/FEIBusiness Operations
    ECOSEM CO., LTD695632865manufacture(80082-201)
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