Code of Federal Regulations Title 21. Food and Drugs § 21.358.550 Labeling of corn and callus remover drug products

(1) “For the removal of corns and calluses.”

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain the following statement:  “Relieves pain by removing corns and calluses.”

(1) For products containing any ingredient identified in § 358.510.

(2) For any product formulated in a flammable vehicle.

(3) For any product formulated in a volatile vehicle. “Cap bottle tightly and store at room temperature away from heat.”

(4) For any product formulated in a collodion-like vehicle.

(1) For products containing salicylic acid identified in § 358.510(a). “Wash affected area and dry thoroughly.” (If appropriate:  “Cut plaster to fit corn/callus.”) “Apply medicated plaster. After 48 hours remove the medicated plaster. Repeat this procedure every 48 hours as needed for up to 14 days (until corn/callus is removed).” (Optional:  “May soak corn/callus in warm water for 5 minutes to assist in removal.”)

(2) For products containing salicylic acid identified in § 358.510(b). “Wash affected area and dry thoroughly. Apply” (select one of the following, as appropriate:  “one drop” or “small amount”) “at a time with” (select one of the following, as appropriate:  “applicator” or “brush”) “to sufficiently cover each corn/callus. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed).” (Optional:  “May soak corn/callus in warm water for 5 minutes to assist in removal.”)