Code of Federal Regulations Title 21. Food and Drugs § 21.350.50 Labeling of antiperspirant drug products

(1) For any product, the labeling states [select one of the following:  “decreases,” “lessens,” or “reduces”] “underarm” [select one of the following:  “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”].

(2) The labeling may state “also [select one of the following:  ‘decreases,’ ‘lessens,’ or ‘reduces'] underarm [select one of the following:  ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”.

(3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24–hour period, the labeling may state [select one of the following:  “all day protection,” “lasts all day,” “lasts 24 hours,” or “24 hour protection”].

(4) For products that demonstrate extra effectiveness (30 percent sweat reduction), the labeling may state “extra effective”.

(5) Products that demonstrate extra effectiveness (30 percent sweat reduction) sustained over a 24–hour period may state the claims in paragraphs (b)(3) and (b)(4) of this section either individually or combined, e.g., “24 hour extra effective protection”, “all day extra effective protection,” “extra effective protection lasts 24 hours,” or “extra effective protection lasts all day”.

(1) “Do not use on broken skin”.

(2) “Stop use if rash or irritation occurs”.

(3) “Ask a doctor before use if you have kidney disease”.

(4) For products in an aerosolized dosage form.