Label: CRAYOLA HAND SANITIZING FOAM- benzalkonium chloride spray

  • 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 May 25, 2010

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial

  • Uses

    Decrease bacteria on skin

  • Warnings

    • For external use only
    • keep out of reach of children except under adult supervision
    • If swallowed, get medical help or contact a Poison Control Center right away.
    • Do not use in eyes.
    • Discontinue use if irritation or redness develop. If condition persists consult a doctor.
  • Directions

    • Turn pump heads to open position and push down
    • Wet palms of hands thoroughly with product
    • Wipe hands and face and then allow skin to dry
  • Inactive Ingredients

    Cetrimonium chloride, D and C Green 5, D and C Red 33, FD and C Yellow 5, Disodium EDTA, DI water, Fragrance

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  • INGREDIENTS AND APPEARANCE
    CRAYOLA HAND SANITIZING FOAM 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride.0013 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    cetrimonium chloride (UNII: UC9PE95IBP)  
    edetate disodium (UNII: 7FLD91C86K)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (D and C green 5) , red (D and C red 33) , yellow (FD and C yellow 5) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48871-005-0112 in 1 CASE
    19 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/2010
    Labeler - Health-Tech, Inc. (084007889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health-Tech, Inc.084007889manufacture
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