---
kind: "section"
citation: "21 C.F.R. § 350.50"
title: "21"
number: "350.50"
heading: "Labeling of antiperspirant drug products."
url: "https://uscodex.org/cfr/21/350.50"
---

# §350.50. Labeling of antiperspirant 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 an “antiperspirant.”
- (b) **Indications.** The labeling of the product states, under the heading “Uses,” the phrase listed in [paragraph (b)(1)](#b-1) of this section and may contain any additional phrases listed in [paragraphs (b)(2) through (b)(5)](#b-2..b-5) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in [paragraphs (b)(1) through (b)(5)](#b-1..b-5) 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 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)](#b-3) and [(b)(4)](#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”.
- (c) **Warnings.** The labeling of the product contains the following statements under the heading “Warnings”:
  - (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.**
    - (i) “When using this product [bullet] 1 keep away from face and mouth to avoid breathing it”.
    - (ii) The warning required by [§ 369.21](/cfr/21/369.21.md) of this chapter for drugs in dispensers pressurized by gaseous propellants.
- (d) **Directions.** The labeling of the product contains the following statement under the heading “Directions”: “apply to underarms only”.

## Notes

### Authority

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

### Source

Source: 68 FR 34291, June 9, 2003, unless otherwise noted.