Label: PURE SOLUTIONS HAND SANITIZING- ethanol solution

  • 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 May 12, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 83% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings
    For external use only.
    Flammable. Keep away from heat or flame.

    When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally to hands to cover all surfaces
    • rub hands together until dry
    • supervise children under 6 years old
    • not recommended for infants
  • STORAGE AND HANDLING

    Other information

    store between 15-30°C (59-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, hydroxyethylcellulose, sodium hydroxide, water

  • SPL UNCLASSIFIED SECTION

    Pure Solutions is a registered trademark of Urban Attitudes Holdings Ltd.

    Distributed by:

    Urban Attititudes Holdings Ltd.

    Great Neck, NY 11023

    (516) 206-3672

    MADE IN PERU

  • PRINCIPAL DISPLAY PANEL

    puresolutions

    Hand Sanitizing Solution

    Non-Sterile Solution

    1.057 GALLONS (4 LITERS)

    Pure Solutions 4 L Final

  • INGREDIENTS AND APPEARANCE
    PURE SOLUTIONS HAND SANITIZING 
    ethanol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77185-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL83 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77185-002-044 L in 1 BOTTLE; Type 0: Not a Combination Product05/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/12/2020
    Labeler - Urban Attitudes Holdings Ltd (117502692)
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