Label: WINTER IN VENICE HOSPITAL GRADE HAND SANITIZER- 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 5, 2020

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  • Drug Facts

  • Active ingredient 

    Alcohol Denat. 72%

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use  • Hand Sanitiser to help reduce bacteria on the skin.

  • Warnings

    For external use only. • Flammable. Keep away from heat or flame.

    When using this product

    • Keep out of eyes, ears, and mouth. In case of contact with eyes, 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.

  • DOSAGE & ADMINISTRATION

    Directions • Dispense a small amount onto dry hands and massage well into skin. • Do not rinse.

  • STORAGE AND HANDLING

    Other information • Store under 110°F (43°C)

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua, Glycerin, Carbomer, Rosa Multiflora Extract, Benzalkonium Chloride, Phenoxyethanol, Parfum, Triethanolamine, Ethylhexylglycerin, Citronellol, Geraniol.

  • QUESTIONS

    Questions? +44 845 652 1223

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    CERTIFIED AND PASSED HOSPITAL GRADE AS PER EU STANDARDS

    KILLS GERMS WITHOUT WATER

    KILLS 99.9% OF BACTERIA AND CORONAVIRUS

    WINTER IN VENICE HOSPITAL GRADE ANTIBACTERIAL HAND SANITISER PROVIDES LONG-LASTING ANTIMICROBIAL PROTECTION FOR THE SKIN WITHOUT SOAP AND WATER.

    • EN 14476
    • EN 1276
    • EN 1500
    • EN 1650
    • EN 13624
    • EN 13727

    • Antibacterial according to EN 1276, EN 1500 and EN 13727

    • Virucidal according to EN 14476

    • Fungicidal and Yeasticidal according to EN 1650 and EN 13624

    Manufactured for

    Winter in Venice

    Dalton House, 60 Windsor Avenue,

    London. SW19 2RR. UNITED KINGDOM

    www.winterinvenice.co.uk

    Designed and formulated in the UK

    Assembled in Turkey

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    WINTER IN VENICE HOSPITAL GRADE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78609-124
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ROSA MULTIFLORA WHOLE (UNII: XZ57EQ287T)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78609-124-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/2020
    2NDC:78609-124-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/2020
    3NDC:78609-124-555000 mL in 1 CAN; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/26/2020
    Labeler - WIV Global Limited (211563238)
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