Label: SANI PROFESSIONAL BRAND SANI-HANDS FOR KIDS 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 February 27, 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 immediately.

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


    Packet Directions
    • Tear open packet.
    • Open and unfold wipe.
    • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe.
    • For dirty hands, use first wipe to clean hands, then discard wipe, sanitize with second wipe.
    • Discard after single use.
    Car cup Canister Directions
    • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep cap closed to prevent moisture loss.
    • Thoroughly wipe hands, fingers, and wrists. Be sure to use entire wipe.
    • For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with second wipe.
    • Discard after single use.
    Canister Directions
    • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover.
    • Wet hands thoroughly with wipe and allow to dry without wiping.
    • Discard after single use.
  • Other information

    Lot No. and Expiration Date can be found on the lid.

    Dosage


    For dirty hands, 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

    (C) 2011 Manufactured for: PDII/Nice-Pak Products, Inc.
    2 Nice-Pak Park, Orangeburg, NY 10962-1376   Made in USA

    *Wipes composed of 50% Tencel, 50% Viscose, both made from renewable resources.

    Tencel(R) is a registered trademark of Lenzing AG.

  • Principal Display Panel - 40 Count Canister

    Sani
    Professional(TM)
    Brand
    SANI-HANDSTM for Kids
    Instant Hand Sanitizing Wipes

    #1 in Hospitals and Doctors' Offices

    Clinically Proven More Effective than Gels
    Kills 99.99% of Germs
    Made with Ultra Soft Tencel(R)*

    Image of front canister label
    Image of back canister label
    Image of car cup canister label
    Image of packet Label
    Image of box label
  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    SANI PROFESSIONAL BRAND SANI-HANDS FOR KIDS  INSTANT HAND SANITIZING WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-7004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.659 mL  in 1 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:10819-7004-5266.56 mL in 1 CANISTER
    2NDC:10819-7004-4126.91 mL in 1 CANISTER
    3NDC:10819-7004-324 in 1 BOX
    34.2 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2011
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-7004)
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