Label: SANI-HANDS II 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 December 20, 2011

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  • Uses


    • For hand sanitizing to decrease bacteria on the skin.
    • Apply topically to the skin to help prevent cross-contamination.
    • 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


    • To start feed: Remove cover and discard seal from container. From center of wipe roll, pull up wipe corner; tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover. Pull through about one inch. Replace cover. Pull out wipes as needed and snap off at a 90o angle. Keep center 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.
  • Other information

    Lot No. and Expiration Date can be found on canister.

    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

    Professional Disposables International, Inc.
    Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
    www.saniprofessional.com

  • Principal Display Panel - 220 Count Canister

    Sani Hands(R) II

    Instant Hand Sanitizing Wipes

    • Kills 99.99% of Germs (a 4 log10 reduction)
    • Antimicrobial
    • Hand sanitizer to decrease bacteria on skin
    • Safe, gentle and effective
    • Contains an emollient and vitamin E
    220 Wipes
    6 x 7.5 in (15.2 x 19.0 cm)

    Front Canister Label
    Image of Front Canister label

    Back Canister Label
    Image of Back Canister


  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    SANI-HANDS II  INSTANT HAND SANITIZING WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-5802
    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:10819-5802-3814 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2007
    Labeler - Profesional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Profesional Disposables International, Inc.800777117manufacture
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