Label: PDI SANI-HANDS ALC ANTIMICROBIAL ALCOHOL GEL HAND 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 21, 2011

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  • Uses

    • Antiseptic
    • For hand washing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care or treatment
    • 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 out of reach of children unless under adult supervision.
  • Directions


    • Tear open packet.
    • Open and unfold towelette.
    • Wipe hands, fingers, interdigital areas and wrists thoroughly with towelettes. Be sure to utilize the entire wipe surface. Allow to dry.
    • If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.
    • Discard after single use.
  • Other information

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

    Dosage


    If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe. Sanitize with a 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.pdipdi.com                  Made in USA

  • Principal Display Panel - 100 Packets per Box

    Clean and Moisturizes

    Sani-Hands(R) ALC
    Antimicrobial Alcohol Gel Hand Wipes

    An Antiseptic handwash to help prevent cross contamination.

        * Kills 99.99% of Germs

        * Contains moisturizing aloe, glycerin and Vitamin E

    Removes Soil and Bacteria More Effectively than Gels Alone

    100 Wipes
    5 x 8 in (12.7 x 20.3 cm)

    Packet Label

    Image of Packet Label

    Box Label

    Image of Box Label

  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    PDI SANI-HANDS ALC  ANTIMICROBIAL ALCOHOL GEL HAND WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-5000
    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:10819-5000-1100 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2008
    Labeler - Profesional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Profesional Disposables International, Inc.800777117manufacture
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