Label: HAND SANITIZER- ethyl alcohol gel

  • 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 October 27, 2022

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  • DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use ​Decreases bacteria on hands

  • WARNINGS

    Warnings For external use only

    Flammable Keep away from fire or flame

    Keep out of eyes In case of eye contact, immediately flush with water and get medical help.

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions Squeeze onto hands and rub hands together briskly until dry.

    Do Not Store Above 110°F

    Non-staining, may discolor certain fabrics.

  • Inactive Ingredients

    Deionized Water, Carbomer, Triethanolamine, Aloe Barbadensis Gel, Fragrance Glycerin, Propylene Glycol, Vitamin E.

  • SPL UNCLASSIFIED SECTION

    Made in China.

    http://ps.ppa.org/hsan

  • Packaging

    Hndsntr

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73752-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73752-319-2050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/02/2020
    Labeler - Specialty Graphics (009901800)
    Establishment
    NameAddressID/FEIBusiness Operations
    YUYAO WANGCHENG DAILY COMMODITY CO., LTD.554527592manufacture(73752-319)