Label: PDI SANI-HANDSINSTANT HAND SANI 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 21, 2013

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  • Uses

    • Antiseptic.
    • For handwashing 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 this out of reach of children unless under adult supervision.
  • Directions

    • To start feed: Remove cover and discard seal from container. From center of toweled 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 cap closed to prevent evaporation.
    • 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 canister

    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

    PDI SANI-HANDS(R)
    Instant Hand Sanitizing Wipes

    • Cleans and Sanitizes Hands
    • Kills 99.99% of Germs
    • Safe to Use Before Eating and Drinking
    • Contains Moisturizing Aloe and Vitamin E

    #1 Hand Wipe in Healthcare

    Front Canister Label 220 ct
    Image of Front Canister 220 ct
    Back Canister Label 220 ct
    Image of Back Canister 220 ct
    Front Canister Label 135 ct
    image of front canister 135 ct
    Back Canister Label 135 ct
    image of back canister 135 ct

  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    PDI SANI-HANDSINSTANT HAND SANI  INSTANT HAND SANITIZING WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-5814
    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:10819-5814-2814 mL in 1 CANISTER
    2NDC:10819-5814-1500 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2008
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-5814)
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