Label: CRAYOLA RADICAL RED ROLL ON HAND SANITIZER- benzalkonium chloride gel

  • 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 Ingredients

    Active Ingredients: Benzalkonium Chloride - 0.13%

    Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to 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 the eyes. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.


  • Directions

    Remove cap. roll over palms and fingers to wet hands thoroughly. Allow to dry without wiping.

  • INACTIVE INGREDIENT

    Aloe, Vera, Cetrimonium Chloride, Citrus Fragrance, Disodium EDTA, D and C red 33, FD and C yellow 5, Luvigel, Water

  • radical red label

    MM18Crayola radical red roll on label

  • radical red blister card

    MM19Crayola radical red roll on blister

  • Crayola shipper roll on label

    MM17Crayola roll on shipper label

  • INGREDIENTS AND APPEARANCE
    CRAYOLA RADICAL RED ROLL ON HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-007
    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
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (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:48871-007-014 in 1 CASE
    16 in 1 CARTON
    11 in 1 BLISTER PACK
    120 mL in 1 BOTTLE
    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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