FOOT WORKS CRACKED HEEL- lidocaine, benzalkonium chloride  cream 
Avon Products, Inc.

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.

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Drug Facts

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

     Purpose

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

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
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.

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

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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

Revised: 5/2012
Document Id: d16052fb-5197-4680-b1fa-6dc03084fc53
Set id: b03b24ce-0790-4b79-ae7c-d2e734e18472
Version: 1
Effective Time: 20120530
 
Avon Products, Inc.