---
kind: "section"
citation: "21 C.F.R. § 344.52"
title: "21"
number: "344.52"
heading: "Labeling of ear drying aid drug products."
url: "https://uscodex.org/cfr/21/344.52"
---

# §344.52. Labeling of ear drying aid 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 “ear drying aid.”
- (b) **Indications.** The labeling of the product states, under the heading “Use,” the following: “dries water in the ears” (optional, which may be followed by: “and relieves water-clogged ears”) (which may be followed by any or all of the following: “after: [bullet] 1 swimming [bullet] showering [bullet] bathing [bullet] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed 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.
- (c) **Warnings.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) “Flammable [in bold type]: Keep away from fire or flame.”
  - (2) “Do not use [in bold type] in the eyes.”
  - (3) “Ask a doctor before use if you have [in bold type] [bullet] ear drainage or discharge [bullet] pain, irritation, or rash in the ear [bullet] had ear surgery [bullet] dizziness.”
  - (4) “Stop use and ask a doctor if [in bold type] irritation (too much burning) or pain occurs.”
- (d) **Directions.** The labeling of the product contains the following statement under the heading “Directions”: [optional, bullet] “apply 4 to 5 drops in each affected ear.”

## Notes

### Amendments

[65 FR 48905, Aug. 10, 2000]

### Authority

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

### Source

Source: 51 FR 28660, Aug. 8, 1986, unless otherwise noted.

### Amendments

[65 FR 48905, Aug. 10, 2000]