SANI-HANDS FOR KIDS ANTIBACTERIAL MOIST WIPES (BENZALKONIUM CHLORIDE) CLOTH [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]

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SANI-HANDS FOR KIDS ANTIBACTERIAL MOIST WIPES (BENZALKONIUM CHLORIDE) CLOTH [PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.]
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NDC 10819-7010-1
Set ID e72f98ab-a657-455d-83ed-ad2a6d01a249
Category HUMAN OTC DRUG LABEL
Packager Professional Disposables International, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    • For external use only.
    • If swallowed, get medical help or contact a Poison Control Center right away.
    • Do not use in the eyes.
    • Flammable, keep away from fire or flame.
    • Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.
  • Directions

    • Peel back label slowly.
    • Pull out wipe and reseal label.
    • Unfold and use; discard after single use.
    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other information

    Lot No. and Exp. date - on side

    Dosage

    Wet hands thoroughly with product and allow to dry without wiping.

  • Inactive ingredients

    Water, SD Alcohol 40, Sorbic Acid, PPG-2 Hydroxyethyl Cocamide, Disodium EDTA, Aloe Barbadensis Leaf Juice, Fragrance

  • SPL UNCLASSIFIED SECTION

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

  • Principal Display Panel - 10 Count

    Sani-Hands for Kids
    Antibacterial Moist Wipes
    Kills 99.99% of Germs
    Moisturizes with Aloe

    15 wipes per Paks [5.0 in x 8.0 in (12.7 cm x 20.3 cm)] 10 Paks per Tray

    Flow Wrap Label
    Image of pak label
    Reseal label
    image of reseal
    Tray Label
    Image of tray label

  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antiseptic handwash

  • INGREDIENTS AND APPEARANCE
    SANI-HANDS FOR KIDS  ANTIBACTERIAL MOIST WIPES
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-7010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBIC ACID (UNII: X045WJ989B)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MICROCITRUS AUSTRALIS FRUIT (UNII: 9DNS80T428)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-7010-110 in 1 TRAY
    138.3 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2013
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-7010)
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