# 21 CFR § 355.20: Packaging conditions

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-355.20

## Section

- **Citation:** 21 CFR § 355.20
- **Heading:** Packaging conditions
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > Subpart B—Active Ingredients

## Text

(a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the following package size limitations are required for anticaries drug products:
(1) Dentifrices. Dentifrice (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per package.
(2) Preventive treatment gels and treatment rinses. Preventive treatment gel and treatment rinse packages shall not contain more than 120 mg total fluorine per package.
(3) Exception. Package size limitations do not apply to anticaries drug products marketed for professional office use only and labeled in accord with § 355.60.
(b) Tight container packaging. To minimize moisture contamination, all fluoride powdered dentifrices shall be packaged in a tight container as defined as a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure.

## Nearby sections

- [21 CFR § 355.1 § 355.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.1.md)
- [21 CFR § 355.3 § 355.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.3.md)
- [21 CFR § 355.10 § 355.10 Anticaries active ingredients.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.10.md)
- [21 CFR § 355.20 § 355.20 Packaging conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.20.md)
- [21 CFR § 355.50 § 355.50 Labeling of anticaries drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.50.md)
- [21 CFR § 355.55 § 355.55 Principal display panel of all fluoride rinse drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.55.md)
- [21 CFR § 355.60 § 355.60 Professional labeling.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.60.md)
- [21 CFR § 355.70 § 355.70 Testing procedures for fluoride dentifrice drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-355.70.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-355.20. Check the current official text before relying on it. Not legal advice.