Label: ANTIBACTERIAL HAND SANITIZER- alcohol liquid

  • 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 January 9, 2021

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  • Active Ingredient(s)

    Ethyl Alcohol 62%. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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.

  • Do not use

    Do not use in ears and mouth

  • WHEN USING

    When using this product avoid contact with eyes. In case of contact flush eyes with water.

  • STOP USE

    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 on to your palms and thoroughly spread on both hands
    • rub into skin until dry
  • Other information

    • store at 20℃(68℉-77℉)
    • may discolor fabrics
    • do not leave under high heat
  • Inactive ingredients

    Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium EDTA , Tocopheryl Acetate, Deionized Water

  • Package Label - Principal Display Panel

    30 mL NDC: 77165-350-01

    antibacterial hand sanitizer

    1 fl.oz. (30ml)

    2floz

    1floz

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77165-350
    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
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77165-350-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77165-350-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - KLM Promo Products, LLC (017087764)
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