Label: 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 May 22, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

     Antiseptic

  • Use

    • Decrease bacteria and germs on the hands.
    • When water, soap and towel are not available
    • Recommended for repeated use
  • Warnings

    For external use only.

    Flammable.Keep away from fire and flame.

    Do not apply around eyes.

    Do not use in ears and mouth

    When using this product

    avoid contact with eyes. In case of contact, flush eyes with water.

    Avoid contact with broken skin.

    Stop use and ask a doctor if

    irritation or redness develops or persists.

    Keep out of reach of children.

    Children under 6, use only under adult supervision. Not recommended for infants.

  • Directions

    • pump as needed into your palms and thoroughly spread on both hands
    • rub into skin until dry

    Other Information:

    • store at 20 ℃ (68 to 77℉)
    • may discolor fabrics
  • 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:75613-006
    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:75613-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    2NDC:75613-006-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/22/2020
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-006)
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