Label: SANI-HANDS INSTANT HAND SANITIZING WIPES- alcohol cloth

  • 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 November 28, 2013

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  • Uses

    • For hand washing to decrease bacteria on the skin.
    • Recommended for repeated use.
    • Dries in seconds.
  • Warnings

    • Flammable, keep away from fire or flame.
    • For external use only.
    • Do not use in or contact the eyes.
    • Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a physician.
    • If swallowed, get medical help or contact a Poison Control Center right away.

    • Keep this out of reach of children unless under adult supervision.
  • Directions


    • Tear open pouch
    • Open and unfold wipe.
    • Thoroughly wipe hands, fingers and wrists. Be sure to utilize the entire wipe.
    • For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe.
    • Discard after single use.
  • Other information

    Lot No. and Expiration Date can be found on pouch, on packet or on top of carton.

    Dosage

    For dirty hand, use first wipe to clean hands, then discard wipe; sanitize with second wipe. Discard after single use.

  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Carbomer, Aminometyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

  • SPL UNCLASSIFIED SECTION

    *Wipes composed of 50% Tencel,
    50% Viscose, both made from renewable resources.
    Tencel(R) is a registered trademark of Lenzing AG.

    Manufactured for:
    Nice-Pak Products, Inc.
    Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
    Made in USA

  • Principal Display Panel

    Sani
    Professional Brand

    SANI-HANDS(R)
    Instant Hand Sanitizing Wipes

    #1 in Hospitals and Doctors' Offices

    Clinically Proven More Effective than Gels

    Kills 99.99% of Germs

    Pouch Label
    Image of Pouch Label
    Individual packet
    Image of Packet Label
    Box of 24 packets
    Imagfe of Box

  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    SANI-HANDS  INSTANT HAND SANITIZING WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-5811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.659 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-5811-88 in 1 POUCH
    2NDC:10819-5811-924 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/08/2012
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-5811)
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