Label: PDI SANI-HANDS INSTANT HAND SANITIZING WIPES- alcohol cloth

  • NDC Code(s): 10819-3916-1
  • Packager: Professional Disposables International, Inc.
  • 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 October 20, 2022

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  • Uses

    To decrease bacteria on the skin

  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame
    • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • Do not use in or contact with eyes.
    • Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.
  • Inactive ingredients

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

  • Active ingredient

    Ethyl Alcohol 70% by volume

  • Purpose

    Antiseptic

  • Directions

    • Tear open packet
    • Open and unfold wipe
    • Thoroughly wipe hands, fingers and wrists using entire
    • Allow to dry
    • For dirty hands, use first wipe to clean hands, then discard wipe. Sanitize with second wipe.
    • Discard after single use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Other information

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

  • PRINCIPAL DISPLAY PANEL

    packet

    packet

    box

    box

  • INGREDIENTS AND APPEARANCE
    PDI SANI-HANDS  INSTANT HAND SANITIZING WIPES
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3916
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 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:10819-3916-1100 in 1 BOX01/01/2014
    10.7 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2014
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-3916)
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