Label: ASEPSO HAND SANITIZER- alcohol liquid

  • NDC Code(s): 73931-014-01, 73931-014-02
  • Packager: Guangdong Essence Daily Chemical 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 July 4, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 72% v/v

  • Purpose

     Antiseptic

  • Use

    • A hand sanitizer to decrease bacteria on the skin.
    • Recomended for repeated use.
  • Warnings

    For external use only.

    Flammable,

    Keep product away from heat or flame.

    When using this product

    do not use in the eyes, In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develop and persist for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product.
    • Briskly rub hands together until dry
    • Supervise children under 6 years in the use of this product.
  • Inactive ingredients

    Water, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice.

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at68℉ to 77℉ （20℃ to 25℃).
    • May discolor certain fabrics.
  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ASEPSO HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73931-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINe (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73931-014-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/04/2020
    2NDC:73931-014-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/04/2020
    Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Essence Daily Chemical Co., Ltd529796211manufacture(73931-014)
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