Label: 75% ALCOHOL HAND SANITIZER- ethyl alcohol liquid

  • NDC Code(s): 81323-621-01, 81323-621-02, 81323-621-03, 81323-621-04, view more
    81323-621-05, 81323-621-06, 81323-621-07, 81323-621-08, 81323-621-09, 81323-621-10
  • Packager: FUYUE BIO-TECHNOLOGY CO., LTD.
  • 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 January 13, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

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

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

    Stop use and ask a doctor if irritation or redness occurs.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Place enough product in hand palm and rub it until dry.

  • Inactive Ingredients

    Water, Hydroxyethylcellulose, Panthenol, Fragrance

  • SPL UNCLASSIFIED SECTION

    Made In Taiwan

    Manufactured by FU YUE Bio-Technology Co., LTD

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81323-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81323-621-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    2NDC:81323-621-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    3NDC:81323-621-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    4NDC:81323-621-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    5NDC:81323-621-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    6NDC:81323-621-06300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    7NDC:81323-621-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    8NDC:81323-621-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    9NDC:81323-621-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    10NDC:81323-621-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/13/2021
    Labeler - FUYUE BIO-TECHNOLOGY CO., LTD. (656370626)
    Establishment
    NameAddressID/FEIBusiness Operations
    FUYUE BIO-TECHNOLOGY CO., LTD.656370626manufacture(81323-621)
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