Label: SANI-HANDS FOR KIDS ANTIBACTERIAL MOIST WIPES- benzalkonium chloride 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 26, 2013

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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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