Source: https://www.law.cornell.edu/cfr/text/21/358.150
Timestamp: 2015-07-07 18:44:15
Document Index: 406401974

Matched Legal Cases: ['art 358', '§ 358', '§ 330', '§ 358', '§ 358', '§ 358', '§ 358', '§ 358', 'art 358']

21 CFR 358.150 - Labeling of wart remover drug products. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 358 › Subpart B › Section 358.150 21 CFR 358.150 - Labeling of wart remover drug products.
§ 358.150
Labeling of wart remover drug products.
The labeling of the product contains the established name of the drug, if any, and identifies the product as a “wart remover.”
The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
“For the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface.”
“For the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.”
For products containing any ingredient identified in § 358.110.
“If discomfort persists, see your doctor.”
“Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.”
The labeling should contain an appropriate flammability signal word, e.g. “extremely flammable,” “flammable,” “combustible,” consistent with 16 CFR 1500.3(b)(10).
For products containing salicylic acid identified in § 358.110(a).
“Wash affected area.” (Optional: “May soak wart in warm water for 5 minutes.”) “Dry area thoroughly.” (If appropriate: “Cut plaster to fit wart.”) “Apply medicated plaster. Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks.”
For products containing salicylic acid identified in § 358.110(b).
“Wash affected area.” (Optional: “May soak wart in warm water for 5 minutes.”) “Dry area 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 wart. Let dry. Repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks.”
For products containing salicylic acid identified in § 358.110(c).
“Wash affected area.” (Optional: “May soak wart in warm water for 5 minutes.”) “Dry area thoroughly. Gently smooth wart surface with emery file supplied.” (If appropriate: “Cut plaster to fit wart.”) “Apply a drop of warm water to the wart, keeping the surrounding skin dry. Apply medicated plaster at bedtime and leave in place for at least 8 hours. In the morning, remove plaster and discard. Repeat procedure every 24 hours as needed (until wart is removed) for up to 12 weeks.”
The phrase “or podiatrist” may be used in addition to the word “doctor” in any of the labeling statements in this section when a product is labeled with the indication identified in § 358.150(b)(2).
[55 FR 33255, Aug. 14, 1990; 55 FR 37403, Sept. 11, 1990, as amended at 57 FR 44495, Sept. 28, 1992; 59 FR 60317, Nov. 23, 1994]
Title 21 published on 2014-04-01.No entries appear in the Federal Register after this date, for 21 CFR Part 358.