Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The listing for Sensitivity Toothpastes states that the name of the active ingredient(s) is hydrated silica but the labeling lists the active ingredients as potassium nitrate 5% and sodium fluoride 0.1%.
Passage 2Your listing submission for Sensitivity Toothpastes states its dosage form and route of administration as liquid and oral, respectively. However, the product label states it is a foam for dental administration.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 207.49(a)(4)
- 21 CFR 207.49(a)(6)
- 21 CFR 207.57(b)(2)
- 21 CFR 207.33(c)
- 21 CFR 207