Label: BACTEKILL HAND SANITIZER- isopropyl alcohol 70% gel hand sanitizer 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 February 10, 2022

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v. Purpose : Antiseptic

  • SPL UNCLASSIFIED SECTION

  • Purpose

    Hand Sanitizer-Antiseptic

  • Uses

    Hand sanitizing to reduce bacteria on the skin

  • Warnings

    • Flamable. Keep away from fire or flame 
    • For external use only
    • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water 
    • Stop use and ask a doctor if irritation or rash appears and lasts
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • When using

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse, 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.

  • Stop use section

    Stop use and ask a doctor if irritation or rash occurs. These may be a sign of a serious condition.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    • Dispense enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freesing and excessive heat above 43C (110F)
  • Inactive ingredients

    Glycerin, Carbomer 940, Aminomethyl Propanediol, purified water USP

  • Package Label- Principal Display Panel

    4 FL OZ (118 mL)  NDC: 79804-215-04

  • Bactekill hand Sanitizer

    Bactekill Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    BACTEKILL HAND SANITIZER 
    isopropyl alcohol 70% gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79804-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX) 1 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 1 mL  in 1 mL
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79804-215-04118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/28/2020
    Labeler - Eagle Labs (118496872)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Labs118496872manufacture(79804-215)
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