Label: SPA ORIGINALS INSTANT HAND SANITIZER- ethyl alcohol liquid

  • 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 September 23, 2011

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  • Active Ingredient

    Ethyl Alcohol 62% w/w

    Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria on the skin that could cause disease

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only - hands.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a physician

    If skin irritation or rash develops.

    Keep out of reach of children.

    If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

  • Directions

    place enough product in your palm to thoroughly cover your hands.

    rub hands together briskly until dry

    children under 6 years of age should be supervised when using this product.

  • Other information

    store below 105F

    may discolor certain fabircs

    may be harmful to wood finishes and plastics

  • Inactive Ingredients

    carbomer, fragrance, glycerin, triethanolamine, propylene glycol, deionized water, vitamin E, aloe barbadensis gel

  • SPL UNCLASSIFIED SECTION

    *Effective at eliminating 99.9% of many harmful germs and bacterial

    Distributed by:

    Custom Solutions, Inc.
    Lee's Summit, MO 64064
    Made in China

  • PRINCIPAL DISPLAY PANEL

    Kills 99,9% of germs*
    without water or towels

    SPA Originals

    instant hand sanitizer

    Moisturizing with Vitamin E and Aloe

    Fresh Scent

    8fl oz (236mL)

  • Product Label

    Spa Originals Instant Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    SPA ORIGINALS INSTANT HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76405-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76405-010-02236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/22/2011
    Labeler - Custom Solutions, Inc. (966678240)
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