---
kind: "section"
citation: "21 C.F.R. § 355.10"
title: "21"
number: "355.10"
heading: "Anticaries active ingredients."
url: "https://uscodex.org/cfr/21/355.10"
---

# §355.10. Anticaries active ingredients.


The active ingredient of the product consists of any of the following when used in the concentration and dosage form established for each ingredient:

- (a) **Sodium fluoride—**
  - (1) **Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.** Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration ≥650 parts per million (ppm).
  - (2) **Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a powdered dosage form.** Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration of ≥850 ppm for products containing the abrasive sodium bicarbonate and a poured-bulk density of 1.0 to 1.2 grams per milliliter.
  - (3) **Treatment rinses.**
    - (i) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, monobasic, and phosphoric acid to a level of 0.1 molar phosphate ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion concentration of 0.02 percent.
    - (ii) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, dibasic, and phosphoric acid to a pH of 3.5 and which yields an effective fluoride ion concentration of 0.01 percent.
    - (iii) Sodium fluoride 0.02 percent aqueous solution with a pH of approximately 7.
    - (iv) Sodium fluoride 0.05 percent aqueous solution with a pH of approximately 7.
    - (v) Sodium fluoride concentrate containing adequate directions for mixing with water before using to result in a 0.02-percent or 0.05-percent aqueous solution with a pH of approximately 7.
- (b) **Sodium monofluorophosphate—**
  - (1) **Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.** Sodium monofluorophosphate 0.654 to 0.884 percent with an available fluoride ion concentration (consisting of PO3 F= and F− combined) ≥800 ppm.
  - (2) **Dentifrices containing 1,500 ppm theoretical total fluorine in a gel or paste dosage form.** Sodium monofluorophosphate 1.153 percent with an available fluoride ion concentration (consisting of PO3 F= and F− combined) ≥1,275 ppm.
- (c) **Stannous fluoride—**
  - (1) **Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form.**
    - (i) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration ≥700 ppm for products containing abrasives other than calcium pyrophosphate.
    - (ii) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration ≥290 ppm for products containing the abrasive calcium pyrophosphate.
  - (2) **Preventive treatment gel.** Stannous fluoride 0.4 percent in an anhydrous glycerin gel, made from anhydrous glycerin and the addition of suitable thickening agents to adjust viscosity.
  - (3) **Treatment rinse.** Stannous fluoride concentrate marketed in a stable form and containing adequate directions for mixing with water immediately before using to result in a 0.1-percent aqueous solution.

## Notes

### Amendments

[60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996]

### Authority

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

### Source

Source: 60 FR 52507, Oct. 6, 1995, unless otherwise noted.

### Amendments

[60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996]