---
kind: "section"
citation: "21 C.F.R. § 358.550"
title: "21"
number: "358.550"
heading: "Labeling of corn and callus remover drug products."
url: "https://uscodex.org/cfr/21/358.550"
---

# §358.550. Labeling of corn and callus remover drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug, if any, and identifies the product as a “corn and callus remover.”
- (b) **Indications.** The labeling of the product states, under the heading “Indications,” the phrase listed in [paragraph (b)(1)](#b-1) of this section and may contain the additional phrase listed in [paragraph (b)(2)](#b-2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in [paragraph (b)](#b) of this section, may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=a) of the act.
  - (1) “For the removal of corns and calluses.”
  - (2) In addition to the information identified in [paragraph (b)(1)](#b-1) of this section, the labeling of the product may contain the following statement: “Relieves pain by removing corns and calluses.”
- (c) **Warnings.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) **For products containing any ingredient identified in § 358.510.**
    - (i) “For external use only.”
    - (ii) “Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.”
    - (iii) “If discomfort persists, see your doctor or podiatrist.”
  - (2) **For any product formulated in a flammable vehicle.**
    - (i) The labeling should contain an appropriate flammability signal word, e.g., “extremely flammable,” “flammable,” “combustible,” consistent with [16 CFR 1500.3(b)(10)](/cfr/16/1500.3.md?p=b-10).
    - (ii) “Keep away from fire or flame.”
  - (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.**
    - (i) “If product gets into the eye, flush with water for 15 minutes.”
    - (ii) “Avoid inhaling vapors.”
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”:
  - (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.”)
- (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.

## Notes

### Amendments

[55 FR 33261, Aug. 14, 1990, as amended at 57 FR 44494, Sept. 28, 1992]

### Source

Source: 55 FR 33261, Aug. 14, 1990, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 55 FR 33255, Aug. 14, 1990, unless otherwise noted.

### Amendments

[55 FR 33261, Aug. 14, 1990, as amended at 57 FR 44494, Sept. 28, 1992]