Label: HAND SANITIZER- alcohol gel

  • 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 August 9, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

     Antiseptic

  • Use

    Helps reduce bacteria on skin.

  • Warnings

    For external use only

    Flammable. Keep away from fire.

    When using this product

    Do not use on damaged or broken skin. keep out of eyes. In case of eye contact, immediately flush eyes with water then contact physician.

    Stop use and ask a doctor if rah occurs.

    Other Information:

    • Do not store above 110℉

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and rub hands together briskly until dry.
  • Inactive ingredients

    Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium edta, Tocopheryl acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-009
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75613-009-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/09/2020
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-009)