Label: FOOT WORKS CRACKED HEEL- lidocaine, benzalkonium chloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 30, 2012

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  • ACTIVE INGREDIENT

    Active ingredients
    Benzalkonium Chloride 0.13%.......
    Lidocaine 2%.........

         Purpose

    ........First aid antiseptic
    ...........External analgesic

  • INDICATIONS & USAGE

    Uses
    • first aid to help reduce the risk of skin infection in minor cuts, scrapes and burns
    • first aid for the temporary relief of pain in minor cuts, scrapes and burns

  • WARNINGS

    Warnings
    For external use only
    • do not use in the eyes or apply over large areas of the body
    • do not use in large quantities, particularly over raw surfaces or blistered areas
    • consult a doctor in the case of deep or puncture wounds, animal bites, or serious burns
    • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product on the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    Children under 2 years of age:
    • consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients
    WATER/EAU, ISOPROPYL PALMITATE, STEARYL ALCOHOL, CETYL ALCOHOL, GLYCERYL STEARATE SE, UREA, CANOLA OIL/HUILE DE COLZA, DIMETHICONE, TRIETHANOLAMINE, POLYSORBATE 80, BENZYL ALCOHOL, LACTIC ACID, ALLANTOIN, METHYLPARABEN, SD ALCOHOL 40-B.

  • QUESTIONS

    Questions? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of labelimage of labelimage of label

  • INGREDIENTS AND APPEARANCE
    FOOT WORKS  CRACKED HEEL
    lidocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-4423
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1 mL  in 50 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.065 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-4423-150 mL in 1 TUBE
    2NDC:10096-4423-275 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/30/2012
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.005149471manufacture
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