Label: CLEAN HAND SANITIZER- ethyl alcohol spray

  • Category: HUMAN OTC DRUG LABEL

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 December 9, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses • sanitizer spray to help decrease bacteria on the skin

             •recommended for repeated use.

  • WARNINGS

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

  • WHEN USING

    When using this product •avoid contact with eyes • in case of contact, rinse eyes throughtly with water

    •do not apply around eyes, do not use near the eyes and mouth.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if sweallowede, get medical help or contact a Poison Control Center right away.

  • SPL UNCLASSIFIED SECTION

    Other information • do not store above 105F. May discolor some fabrics.

  • DOSAGE & ADMINISTRATION

    Directions • spray enough product in your palms and thoroughly spread on both hands and rub into skin until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis gel, carbomer, fragrance, FD&C blue no. 1, FD&C yellow no.5, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    CLEAN HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58180-210
    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
    ALOE (UNII: V5VD430YW9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58180-210-0110 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/09/2014
    Labeler - Bicooya Cosmetics Limited (421310774)
    Registrant - Bicooya Cosmetics Limited (421310774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bicooya Cosmetics Limited421310774manufacture(58180-210)
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