Label: EGOLAN 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 July 3, 2020

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  • DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use: Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For External use only. Flammable. Keep away from flames. Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and contact doctor if irritation develops or persists for more than 72 hours.

    Keep out of reach of children. If swallowed get immediate medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply onto hands/skin, rub until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Triethanolamine, Carbomer, Aloe Vera Gel, Fragrance, Glycerin, Propylene Glycol, Vitamin E

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL

    KILLS 99.9% GERMS

    Manufacturer:

    Sanrace Biotechnology Co., Ltd

    Manufacturer Address:268 Yanzhou Road,

    Lanxi Development Zone,Zhejiang Province.

    Made In China.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    EGOLAN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75448-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    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:75448-025-20237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/05/2020
    Labeler - Sanrace Biotechnology Co., Ltd. (543000938)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanrace Biotechnology Co., Ltd.543000938manufacture(75448-025)
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