Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 69396-137-10
  • Packager: Trifecta Pharmaceuticals USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2023

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  • Active Ingredient

    Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on skin without soap and water

  • Warnings

    • for external use only
    • Use with caution if allergic to alcohol.
    • Flammable. Keep away from heat or flames.

  • Do not use

    Do not Use

    • in the eyes

  • Directions

    Put enough product on your palm to cover hands and briskly rub hands together until dry.

  • Keep out of reach of Children

    For Children under 6 years old, use only under adult supervision

  • Inactive Ingredients

    Aloe barbadensis leaf juice, Acrylates/C10-30 alkyl acrylate crosspolymer, Fragrance, Glycerin, Maltodextrin, Propylene glycol, Tocopheryl acetate, Triethanoamine, water.

  • Other Information

    • Do not store above 105°F
    • May discolor some fabrics
    • Harmful to wood finishes and plastic

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    1-888-296-9067

  • Package Label

    R519521 Globe Hand Sanitizer 0.9g 10pk 100423 CDER

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-137-1010 in 1 BOX12/03/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/03/2023
    Labeler - Trifecta Pharmaceuticals USA (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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