Label: FOOT WORKS CRACKED HEEL- lidocaine, benzalkonium chloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-4423-1, 10096-4423-2 - Packager: Avon Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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
- INDICATIONS & USAGE
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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 - DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOOT WORKS CRACKED HEEL
lidocaine, benzalkonium chloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-4423 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 1 mL in 50 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.065 mL in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-4423-1 50 mL in 1 TUBE 2 NDC:10096-4423-2 75 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 05/30/2012 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 005149471 manufacture