Label: ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE- 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 October 26, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    - For external use only.
    - Flammable, keep away from fire or flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if

    -irritation and redness develop

    -Condition persists for more than 72 hours

    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 allow to dry without wiping.

  • Other information

    - Store in original packaging in a cool and dry place, out of direct sunlight.

    - May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, glycerin, acrylates/C 10-300 alkyl acrylate crosspolymer, fragrance, triethanolamine, isopropyl myristate.

  • Questions or comments

    1 (224) - 408-0663

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ACTIVEX ANTIBACTERIAL HAND SANITIZER ACTIVE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64309-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64309-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Evyap Sabun Yag Gliserin Sanayi Ve Ticaret Anonim Sirketi (628145740)
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