Label: DRPURX HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 August 2, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest.

    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
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 85°
    • may discolor some fabrics
    • harmful to wood finished and plastics
  • Inactive ingredients

    water, acrylates/C10-30 alkyl acrylate crosspolymer, sodium PCA, hyaluronic acid

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    LoomUSA LLC
    3 Graphics Dr
    Ewing, NJ 08628

    Manufactured by:
    LoomUSA LLC
    FDA Registered Facility

  • PRINCIPAL DISPLAY PANEL - 499.79 mL Bottle Label

    Made in
    the USA

    DrPuRX

    HAND SANITIZER

    Kills more than 99% of infectious agents*

    Moisturizers leavehands smooth

    16.9 FL OZ (499.79mL)

    Principal Display Panel - 499.79 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DRPURX HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80607-921
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80607-921-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    2NDC:80607-921-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    3NDC:80607-921-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    4NDC:80607-921-04118.2 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    5NDC:80607-921-053785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
    6NDC:80607-921-06208197.65 mL in 1 DRUM; Type 0: Not a Combination Product03/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A03/01/2020
    Labeler - Loom USA (117514119)
    Establishment
    NameAddressID/FEIBusiness Operations
    LoomUSA LLC117514119MANUFACTURE(80607-921)
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