Label: LIFEBUOY HAND SANITIZER- alcohol gel

  • NDC Code(s): 73931-015-01, 73931-015-02
  • 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 August 27, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 75% v/v

  • purpose

    antiseptic

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable, Keep away from heat or flame.

    Do not use

    • Onchildren less than 2 months of age
    • On open skin wounds

    When using this product

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

    Stop use and ask a doctor if

    irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

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

  • 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.
  • Inactive ingredients

    Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol

  • SPL UNCLASSIFIED SECTION

    other information

    • Store between 15-30℃ (59-86 ℉)
    • Avoid freezing and excessive heat above 40℃(104℉)
  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    LIFEBUOY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73931-015
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73931-015-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    2NDC:73931-015-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/27/2020
    Labeler - Guangdong Essence Daily Chemical Co., Ltd (529796211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Essence Daily Chemical Co., Ltd529796211manufacture(73931-015)
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