FDA warning letter · Drugs

Shenzhen Hengkaifeng Commerce and Trade Co., Ltd

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The 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 2

Your 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