Label: PDI 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 December 23, 2015

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  • Uses

    • Antiseptic
    • 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 out of reach of children

    unless under adult supervision.

  • Directions


    • Peel back label slowly
    • Pull out wipe and reseal label
    • Unfold and use
    • 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 pack.

    Dosage

    Use first wipe to clean hands, then discard wipe. Sanitize with a second wipe.

  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

  • Manufactured for:

    Professional Disposables International, Inc.
    Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
    Made in USA

    www.pdipdi.com

  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • Principal Display Panel - 20 Count

    lid: label

    flowrap: flowrap

  • INGREDIENTS AND APPEARANCE
    PDI SANI-HANDS INSTANT HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-5808
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-5808-183 mL in 1 PACKAGE; Type 0: Not a Combination Product12/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2011
    Labeler - Professional Disposables International, Inc. (800777117)
    Registrant - Professonal Disposables International, Inc (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guy & O'Neill, Inc.926830563manufacture(10819-5808)
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