Label: AQ PURE INSTANT HAND SANITIZER- 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 July 31, 2020

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  • Drug Facts

  • Active Ingredients

    Alcohol 80%

    Purpose

    Antiseptic

  • Uses:

    • wet hands bacteria on the skin that could disease
    • recommended for repeated uses
  • Directions:

    • wet hands thoroughly with product and allow to dry without wiping
    • not recommende for infants
  • Warnings:

    • For external use only
    • Flammable
    • Keep away from heat and flame
    • Do not store above 40 degrees Celcius (15 degrees Farenheit)

    Do not use

    • in mouth, ears or eyes

    When using this product,

    • avoid contact with eyes
    • In case of contact, flush eyes with water

    Stop use and seek a doctor

    • if redness or irritation develops and persist for more than 72 hours
    • Children must be supervise in use of this product
    • Pump as needed into your palms and thoroughly spread on both hands
    • Rub in to skin until dry

    Keep out of reach of children

    • children must be supervised in the use of this product
  • Other Information:

    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients:

    • water
    • triethanolamine
    • acrylates/c 10-30 alkyl crosspolymer
    • glycerin
  • Package Labeling:290ml

    Bottle

  • Package Labeling:480ml

    Bottle2

  • INGREDIENTS AND APPEARANCE
    AQ PURE INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79333-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79333-001-07290 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    2NDC:79333-001-08480 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/13/2020
    Labeler - DAY GREAT LLC (122472915)
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